SNPMiner Trials (Home Page)
Report for Mutation V158M
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 26 clinical trials
Clinical Trials
1 Clinical Studies of Mental Illness Not Involving Treatment Development, Efficacy, or Effectiveness Trials Phenotype-genotype Predictors of Cognitive Outcomes in Geriatric Depression
Late-life depression (LLD) and cognitive impairment (CI) are significant public health problems among older adults, and their co-occurrence markedly increases disease burden and dementia risk. This highlights the importance of identifying and treating CI in LDD; however, current lack of reliable prognostic information from clinical, neuroimaging, and genetic data impedes research on targeted prevention and treatment. Two critical ways to close current knowledge gaps in predicting cognitive diagnostic outcomes of LLD involve: 1) increasing the number of diagnostic cases available to existing studies, and 2) using those studies to identify clinical, imaging, and genetic predictors that will improve future diagnosis. We intend to do both in the current proposal. We plan to study the following SPECIFIC AIMS: Aim 1: Identify baseline clinical-behavioral predictors of cognitive diagnostic outcomes in LLD. Working hypothesis: During acute LLD, CN will be associated with more frequent EOD and higher negative life stress than PCI and AD; PCI will be associated with EOD and higher frailty than CN and AD; AD will be associated with LOD, greater appetite loss, lower anxiety, and greater memory impairment than CN and PCI. Aim 2: Use multimodal neuroimaging at baseline to identify patterns associated with cognitive diagnostic outcomes in individuals with LLD. Working Hypothesis: CN will be associated with greater white matter integrity compared with PCI and AD; PCI will be associated with lower white matter integrity and network abnormalities in anterior cingulate cortex compared with CN; AD will be associated with lower hippocampal volume compared with CN and PCI. Aim 3: (exploratory): Explore interrelationships among candidate genes, cognitive diagnostic outcomes, and proposed phenotypic components relevant to LLD. Exploratory Hypotheses: 1) COMT val158met polymorphism will be associated with CN; 2) 5-HTTPRL and APOE ε2 polymorphisms will be associated with frailty; 3) genetic variation (SNPs) in TPH2 and AGTR1 will be associated with risk factors of AD: LOD, episodic memory, hippocampal volume, and appetite loss.
NCT00570583 Major Depression Dementia MeSH:Dementia Depression Depressive Disorder
HPO:Dementia Depressivity
Exploratory Hypotheses: 1) COMT val158met polymorphism will be associated with CN; 2) 5-HTTPRL and APOE ε2 polymorphisms will be associated with frailty; 3) genetic variation (SNPs) in TPH2 and AGTR1 will be associated with risk factors of AD: LOD, episodic memory, hippocampal volume, and appetite loss. --- val158met ---
Specifically, CN individuals will have earlier first onset of depression (EOD) relative to AD, more negative life stress during acute depression compared with AD and PCI, and greater white matter integrity; CN will also be associated with the AA genotype of the COMT val158met polymorphism, which may confer both neuroprotection and higher stress sensitivity. --- val158met ---
Primary Outcomes
Measure: Change in Depression status (measured by Montgomery Asberg Depression Rating Scale) Time: Minimum of once per year, up to 21 yearsMeasure: Change in Cognitive impairment (as measuring using cognitive tests including those found in the CERAD battery) Time: Once per year, up to 21 years
Measure: Development of dementia (Determined by Clinical Consensus Conference) Time: once per year, up to 14 years
Secondary Outcomes
Measure: Change in Cognition (as measured by tests including those in the CERAD battery) Change in Brain MRI markers (e.g., volume of white matter and gray matter lesions) Time: once per year, up to 21 yearsMeasure: Change in Impairment in Instrumental or Basic Activities of Daily Living Time: at least once per year, up to 21 years
Measure: Packing density of prefrontal cortex neurons with pyramidal morphology in post-mortem neuroanatomical studies Time: once post-mortem
2 The Effect of Perioperative Intravenous Low-dose Ketamine on Acute and Chronic Neuropathic Pain After Major Back Surgery. A Randomised, Placebo-controlled, Double-blind Study
After a surgical operation, patients may suffer from chronic pain. Ketamine, a well known anesthetic acts on receptors in the spine (NMDA receptors), which are implied in the occurrence of chronic pain. The mechanism is called central sensation. It is known that Ketamine reduces immediate postoperative pain, but its effectiveness in the prevention of the chronic pain is still unknown. The investigators study will follow patients until one year after operation for the occurrence of chronic pain. The investigators hypothesis is that Ketamine reduces significantly chronic postoperative pain after major back surgery and improves patient outcome. There may be important inter-individual differences how persons react on a drug. These differences are partly determined by the genes of each individual. The investigators study includes therefore a genetic analysis. Psychological and social factors also influence the perception of pain. It is still not well understood who these "psychosocial factors" determine the appearance and perception of chronic pain. In the investigators study the investigators will therefore study these factors by questionnaires.
NCT00618423 Postoperative Pain Drug: Placebo Drug: Ketamine MeSH:Pain, Postoperative
As for pain sensitivity and morphine response variability, the met allele at the val158met polymorphisms in the catechol-O-methyltransferase gene (COMT), reduces the ability of the enzyme to metabolize catecholamines, and has been associated with a decrease in opioid consumption in cancer pain patients. --- val158met ---
Primary Outcomes
Measure: To evaluate the long-term (6 and 12 months) effect of perioperative intravenous low-dose ketamine on chronic neuropathic pain in patients undergoing major back surgery. Time: one yearSecondary Outcomes
Measure: To evaluate the short-term (during hospitalisation) effect of perioperative intravenous low-dose ketamine in patients undergoing major back surgery: tolerability and safety, opioid-sparing effect, pain intensity, morphine-related adverse effects. Time: one weekMeasure: To study the potential impact of genetic variability of several enzymes (CYP2D6, CYP2C9, COMT) known to modulate pain sensitivity and/or metabolism of opioid and NSAIDs on analgesic consumption and ketamine response. Time: immediate
Measure: To study psychosocial factors that may be involved in the perception of acute and chronic postoperative pain in patients with or without chronic back pain undergoing back surgery. Time: one year
Measure: To study the pharmakokinetics of an intravenous low-dose ketamine infusion. Time: one day
3 Age-17 Follow-up of Home Visiting Intervention
This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.
NCT00708695 Antisocial Behavior Psychopathology Substance Use HIV Infections Behavioral: Nurse Home Visiting MeSH:HIV Infections
2. Effects on youth violent antisocial behavior, SUDs, and risky sexual behavior will be more pronounced among males with the MAOA-LPR low activity alleles compared to males with MAOA-LPR high activity alleles, and among both males and females with 2 copies of the high-activity Val allele of the COMT Val158Met polymorphism compared to those with 2 copies of the low-activity met allele or heterozygotes. --- Val158Met ---
Primary Outcomes
Description: Public benefit expenditures estimated from review of state administrative records and maternal report of all children's birth dates. Program effects on public-benefit expenditures hypothesized to be especially pronounced for mothers with higher psychological resources.
Measure: Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). Time: through first child age 18Description: Direct tests of youth cognitive, language, and academic functioning. Program effects in this domain hypothesized to be most pronounced for children born to mothers with low psychological resources.
Measure: Cognitive, language, and academic functioning among first-born children. Time: at youth age 18Description: Measure of internalizing disorders based upon youth self-report.
Measure: Youth depression and anxiety Time: at youth age 18Description: Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females.
Measure: Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence. Time: at youth age 18Description: Outcomes based upon self-report and urine assays for STI's and substance use.
Measure: Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. Time: at youth age 18.Secondary Outcomes
Description: Based upon maternal self-report of SUDs and depression.
Measure: Reduced maternal substance use disorders (SUDs) and depression. Time: at youth age 18Description: Based upon direct tests of risky decision making, impulsivity, facial recognition, verbal working memory) and records of high school graduation. Program effects in this domain hypothesized to be more pronounced for children born to mothers with low psychological resources.
Measure: Improved child executive cognitive functioning, and rates of high school graduation. Time: at youth age 18Other Outcomes
Description: Self-reported number of subsequent pregnancies, pregnancy outcomes, live births, low-birth weight newborns, and birth dates. Program effects on cumulative pregnancies and births hypothesized to be more pronounced among mothers with high psychological resources.
Measure: Cumulative subsequent pregnancies - mothers Time: through youth age 18Description: Self-reported pregnancies and pregnancy outcomes.
Measure: Pregnancies - youth Time: through youth age 18Description: Self-reported duration and quality of relationship, cohabitation, marriage, partner employment, and relationship to first-born child
Measure: Relationship with Current Partner Time: at youth age 184 Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE
This is a genetic association study of cognitive impairment in young bipolar disease type I patients without medications in mania, depression, hypomania or mixed states.
NCT00969930 Bipolar
Methods: 80 patients with BD type I (SCID DSM-IV), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for COMT (val158met, rs165599, -287, rs737865), ApoE (epsilon 4) and BDNF (val66met)and 80 healthy controls. --- val158met ---
Primary Outcomes
Measure: Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms Time: 18 months5 Remediation of Working Memory in Schizophrenia
The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.
NCT00995553 Schizophrenia Schizoaffective Disorder Behavioral: Cognitive Remediation Behavioral: Computer Skills MeSH:Schizophrenia Psychotic Disorders
HPO:Psychosis Schizophrenia
The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. --- Val158Met ---
Primary Outcomes
Description: The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.
Measure: Cognitive Assessment - MATRICS Consensus Cognitive Battery Time: Post-intervention, within 2 weeks of completion of the 4 month interventionSecondary Outcomes
Description: The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.
Measure: Functional Capacity - University of California, San Diego Performance-Based Skills Assessment Time: Post-intervention, within 2 weeks of completion of the 4 month intervention6 A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol
This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets NET, neither of which has heretofore been examined in the context of alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will provide the PI with sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence. Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo. Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.
NCT01408589 Alcohol Craving Mood Changes Drug: Atomoxetine, Strattera
COMT Val158Met (G/A), Val > Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined. --- Val158Met ---
Primary Outcomes
Description: Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS
Measure: Alcohol Craving Time: Day 5 of medicationSecondary Outcomes
Description: To determine whether two functional SNPs within the COMT and DBH genes moderate the effects of EtOH and or atomoxetine. COMT Val158Met (G/A), Val > Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined
Measure: Genetic moderation Time: day 5 of medication7 Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia
Cognitive training is moderately effective at reducing symptoms and improving life function in schizophrenia patients. The present application develops a strategy for increasing the effectiveness of cognitive training through the use of pro-cognitive medications. Specific biomarkers will be studied that identify patients most sensitive to these pro-cognitive medications, to test the feasibility of using these biomarkers in a large clinical trial of medication-enhanced cognitive training in schizophrenia.
NCT01555697 Schizophrenia Drug: Memantine Drug: Placebo MeSH:Schizophrenia
HPO:Schizophrenia
PPI-enhancing effects of MEM in healthy subjects are associated with: 1) increased WM; and 2) phenotypes linked to the high activity Val158Met COMT polymorphism. --- Val158Met ---
Primary Outcomes
Description: Prepulse inhibition of the startle reflex
Measure: Prepulse inhibition Time: 3 yearsSecondary Outcomes
Description: MATRICS Consensus Cognitive Battery Performance
Measure: MATRICS Time: 3 years8 COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence
The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.
NCT01570699 Opioid-related Disorders Opiate Dependence Opiate Addiction Opiate Abuse Genetic: COMT polymorphism MeSH:Opioid-Related Disorders
COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence. --- Val158Met ---
Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. --- Val158Met ---
Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. --- Val158Met --- --- Val158Met ---
Inclusion Criteria: - Patient over 18 years old - Caucasian patients - Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine)) - Not lifetime history of opioid dependence (DSMIV) - Patients with health insurance coverage - Patient was treated with opioids analgesics to alleviate 2 or 3 in their lives Exclusion Criteria: - Non-Caucasian patients - Patients who cannot give their consent and/or who refuse the collection of genetic data - Patients with no health insurance coverage Inclusion Criteria: - Patient over 18 years old - Caucasian patients - Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine)) - Not lifetime history of opioid dependence (DSMIV) - Patients with health insurance coverage - Patient was treated with opioids analgesics to alleviate 2 or 3 in their lives Exclusion Criteria: - Non-Caucasian patients - Patients who cannot give their consent and/or who refuse the collection of genetic data - Patients with no health insurance coverage Opioid-related Disorders Opiate Dependence Opiate Addiction Opiate Abuse Opioid-Related Disorders The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders, including addictions, as well as in impulsivity. --- Val158Met ---
Primary Outcomes
Measure: Number of subjects with each COMT genotype (Val/Val, Val/Met and Met/Met) in the opiate-users' group and in the opiate-dependent subjects' group Time: Day 0Secondary Outcomes
Measure: Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion Time: Day 0Measure: Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion Time: Day 0
Measure: Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion Time: Day 0
Measure: Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion Time: Day 0
Measure: Score on the ASRS(Self-Report Scale) on the day of the inclusion Time: Day 0
Measure: Score on the MOPS (Measure Of Parental Style) on the day of the inclusion Time: Day 0
Measure: Score on the Questionnaire of family breakdowns on the day of the inclusion Time: Day 0
Measure: Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion Time: Day 0
Measure: Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion Time: Day 0
9 Clozapine for Cannabis Use Disorder in Schizophrenia
Many individuals with schizophrenia also suffer from marijuana addiction that worsens their problems related to schizophrenia. Most of the medications prescribed for schizophrenia have no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not commonly used due to its side effects and is reserved for people who do not respond to other antipsychotic medications. In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a cannabis use disorder will be randomized to a 12-week treatment course with either clozapine or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis that patient treated with clozapine will have decreased cannabis use as compared to patients treated with risperidone. Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with schizophrenia more than risperidone, it will provide evidence needed to begin to shift clinical practice toward its use in this population.
NCT01639872 Schizophrenia Cannabis Abuse Cannabis Dependence Dual Diagnosis Drug: Clozapine Drug: Risperidone MeSH:Marijuana Abuse Schizophrenia
HPO:Schizophrenia
Finally, this study will explore whether those patients with the val/val genotype at the Catechol-O-methyltransferase (COMT) Val158Met locus are more likely to decrease cannabis use during CLOZ treatment than are those without the val/val COMT genotype. --- Val158Met ---
Primary Outcomes
Description: Intensity of cannabis use is obtained each week retrospectively as the number of joints smoked during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Measure: Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) Time: 12 weeksDescription: Frequency of cannabis use is obtained each week retrospectively as the number of days of cannabis use during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Measure: Average Over Time of Frequency of Cannabis Use Time: 12 weeks10 Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool
Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.
NCT01699711 Down Syndrome (DS) Dietary Supplement: Epigallocatechin-3-gallate (EGCG) MeSH:Down Syndrome
COMT val158met genetic polymorphism (catechol methyl transferase) (Taqman). --- val158met ---
Primary Outcomes
Description: a.Intelligence Quotient [Kaufman (K-BIT)], b.Attention [Spatial Span direct series (SSP), Choice Reaction Time (CRT) CANTAB battery]c. Psychomotor Speed [ (MOT) CANTAB battery] d.Episodic Memory [visuospatial: Paired Associates Learning (PAL) and visual: Pattern Recognition Memory (PRM) CANTAB battery; visuospatial learning Cued Recall Test (CRT) ] e.Executive Functions [working memory: SSP CANTAB battery; verbal semantic fluency; inhibition: Cats and Dogs; planning: Tower of London-Drexel (TOLDX) mental flexibility: Weigl Card Sorting Test ] f.Language:[ Expressive language: Boston naming test (BNT) ; Receptive language: Token Test (TT) g.Functional, quality of life and neuropsychiatric evaluation [Adaptative Behaviour Assessment System (ABAS-II): Dementia Questionnaire for People with Intellectual Disabilities (DMR): Neuropsychiatric Inventory (NPI); quality of life: Kidscreen; semi-structured interview to evaluate subjective effects concerning relevant changes.
Measure: Change in Cognitive Evaluation Time: From predose baseline to 19 months (end of treatment)Description: APP derived amyloid peptides in plasma (INNO-BIA)
Measure: Change in Amyloidosis Biomarkers Time: From predose baseline to 19 months (end of treatment)Secondary Outcomes
Measure: Treatment compliance Time: Predose baseline 3, 7, 13 monthsDescription: LDL (Low density lipoproteins), HDL (High density lipoprotein, cholesterol, triglycerides oxidized-LDL (Pentra Autoanalyzer, and ELISA Mercodia for LDLox
Measure: Change in Biomarkers of lipid oxidation Time: Predose baseline: 3, 7, 13 monthsDescription: Plasma homocysteine (Abbot AxyM), transthyretrin (ELISA) FOXO1 (DNA-binding ELISA nuclear extract from lymphocytes)
Measure: Change in DYRK1A activity biomarkers Time: Predose baseline 4 , 7 and 13 and 19 moths (end of treatment plus 6 months).Measure: COMT val158met genetic polymorphism (catechol methyl transferase) (Taqman) Time: Predose baseline
Measure: Change in AST (SGOT -serum glutamic oxaloacetic transaminase-) and ALT (SGPT- Serum Glutamic Pyruvate Transaminase-) (Pentra Autoanalyzer, and ELISA Mercodia for LDLox) Time: Predose baseline 4 , 7 and 13 and 19 moths (end of treatment plus 6 months).
Measure: Change in Body Composition by electrical impedance (TANITA-MC-180) Time: Predose baseline 4 , 7 and 13 and 19 moths (end of treatment plus 6 months).
Description: Parameters to be evaluated: (i) Motor threshold at Rest (MTR) for the Abductor Pollicis Brevis ( APB) muscle determination (ii) Basal single pulse response at rest for the APB at 110 of the MTR required, and (iii) Percentage of increase and decrease of the amplitude of the APB after double pulse, short and long pulse interval after transcranial magnetic stimulation (TMS).
Measure: Changes in Neurophysiology Time: Predose baseline: 7, 13 monthsDescription: Regional brain morphology and volume (FLAIR) sequence to assess possible white matter tissue macroscopic lesions), brain function in disease-specific neural systems: Intrinsic functional organization (i.e., functional connectivity) in the resting-state within the neural systems.
Measure: Changes in Neuroimaging Time: Predose baseline: 7, 13 months11 Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting - a Randomised, Placebo-controlled, Dose-finding Study
Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia. Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single randomised trial has been published so far that tests the efficacy of dexamethasone for the treatment of established PONV symptoms. In this trial the investigators want to test the antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment of established PONV symptoms. In adjunct protocols of this study the investigators aim to establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study pharmacogenetics of PONV, and to further our understanding on the smoking status as a predictive factor of PONV.
NCT01975727 Postoperative Nausea and Vomiting Vomiting Drug: Placebo Drug: Dexamethasone 3 mg Drug: Dexamethasone 6 mg Drug: Dexamethasone 12 mg MeSH:Nausea Vomiting Postoperative Nausea and Vomiting
HPO:Nausea Vomiting
The COMT enzyme possesses a frequent non-synonymous polymorphism that encodes for the substitution of valine (Val) by methionine (Met) at codon 158 (Val158Met). --- Val158Met ---
The COMT Val158Met polymorphism (rs4680) will be genotyped using a commercially available TaqMan® SNP genotyping assay (C_25746809_50, Applied Biosystems, Warrington, UK). --- Val158Met ---
Primary Outcomes
Description: Complete absence of any nausea and/or vomiting (including retching) in a previously nauseated or vomiting patient within 24 hours after administration of the study treatment.
Measure: Treatment efficacy of Dexamethasone for established PONV Time: 24 hour follow upSecondary Outcomes
Description: Free from PONV during the first 6 hours
Measure: Short term efficacity Time: 6 hoursDescription: Number of patients staying PONV free after rescue antiemetic during the first 24 postoperative hours
Measure: PONV free after rescue antiemtic Time: 24 hour follow upDescription: quality of sleep during the first postoperative night (numerical rating scale ranging from 0 = no sleep at all to 10 = excellent sleep)
Measure: Quality of sleep Time: 24 hour follow upDescription: any minor or major adverse effects during 24h.
Measure: Minor or major adverse effects Time: 24 hour follow up12 A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation
In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are identified by measurement of vigilance and cognitive performance as well as EEG measurements during wake and sleep. - Trial with medicinal product
NCT02080715 Healthy Drug: Tolcapone Drug: Placebo
Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. --- Val158Met ---
Primary Outcomes
Description: Vigilance is measured subjectively (questionnaires and visual analogue scales) and objectively (e.g., psychomotor vigilance task: reaction times and number of lapses; waking EEG: spectral power) at 3-hour intervals during 40 hours prolonged wakefulness in 30 healthy male adults.
Measure: Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo Time: Participants will be studied during two weeks13 Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.
NCT02092974 Healthy Young and Older Adults Procedure: tDCS Drug: Citalopram Other: sham-tDCS + placebo
To assess predictors of SSRI-enhanced brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF, Val66Met, COMT, Val158Met, KIBRA, rs17070145, 5-Hydroxytryptamine transporter).. Inclusion Criteria: - right handedness - unobtrusive neuropsychological screening - ability to provide written informed consent - no pathological findings in head MRI - age: 18 to 35 years (young adults) or 50-80 years (older adults) - Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential Exclusion Criteria: - severe internal or psychiatric disease (especially depression or suicidal thoughts) - epilepsy - cognitive impairment (< SD under age adjusted norm in neuropsychological testing) - concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors - concurrent taking of tramadol or triptans - concurrent taking of pimozide or linezolid - concurrent taking of other drugs prolonging the QT-interval - long-QT-syndrome - hypokalemia or hypomagnesemia - known intolerance of the study medication - claustrophobia or metallic implants, tattoos (MRI exclusion criteria) - pregnancy or lactation - participation in another drug-interventional clinical trial within the last month or during the entire study - probands that are placed in an institution due to official or judicial order - non-agreement to save and transmit pseudonymised study data within the clinical trial Inclusion Criteria: - right handedness - unobtrusive neuropsychological screening - ability to provide written informed consent - no pathological findings in head MRI - age: 18 to 35 years (young adults) or 50-80 years (older adults) - Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential Exclusion Criteria: - severe internal or psychiatric disease (especially depression or suicidal thoughts) - epilepsy - cognitive impairment (< SD under age adjusted norm in neuropsychological testing) - concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors - concurrent taking of tramadol or triptans - concurrent taking of pimozide or linezolid - concurrent taking of other drugs prolonging the QT-interval - long-QT-syndrome - hypokalemia or hypomagnesemia - known intolerance of the study medication - claustrophobia or metallic implants, tattoos (MRI exclusion criteria) - pregnancy or lactation - participation in another drug-interventional clinical trial within the last month or during the entire study - probands that are placed in an institution due to official or judicial order - non-agreement to save and transmit pseudonymised study data within the clinical trial Healthy Young and Older Adults null --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: Recall score immediately after learning phase (=training of visual-spatial abilities) under tDC stimulation + SSRI application compared to learning under tDC stimulation + placebo.
Measure: Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo. Time: immediately after end of learning phase (approx. 1 hour)Secondary Outcomes
Description: Measurement of recall scores on the evening of the same day after the learning phase (+tDCS + SSRI), the morning of the day after and 1 week later in order to assess the prolongation of atDCS induced learning enhancement by the SSRI.
Measure: prolongation of the atDCS induced learning enhancement by SSRI Time: 1 weekDescription: Measurement of recall scores directly after learning phase after application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo.
Measure: Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo Time: immediately after learning phase (approx. 1 hour)Description: Measurement of recall scores on the evening of the same day of learning phase, the morning of the day after and 1 week later under application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo, in order to assess prolongation of learning enhancement by SSRI.
Measure: prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo Time: 1 weekDescription: To assess predictors of SSRI-enhanced brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF, Val66Met, COMT, Val158Met, KIBRA, rs17070145, 5-Hydroxytryptamine transporter).
Measure: genotyping of learning related polymorphisms Time: once14 Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.
NCT02110043 Mild Cognitive Impairment (MCI) Device: tDCS Behavioral: training MeSH:Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).. Inclusion Criteria (MCI patients): - right handedness - amnestic and amnestic plus MCI with: 1. subjective memory impairment; 2. objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values; 3. relatively normal performance in other cognitive domains; 4. no constraints in activities of daily livings 5. age: 50-90 years Exclusion Criteria: - severe internal or psychiatric disease - epilepsy - other severe neurological diseases, e.g. --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
Measure: Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS Time: immediately after end of a 3-day period of training in tDCS condition vs sham conditionSecondary Outcomes
Description: long term effects measured by performance in LOCATO task in tDCS condition after end of cognitve training and after 1 month compared to control conditions
Measure: long term effects Time: after 1 month vs baselineDescription: Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
Measure: functional changes: Connectivity Time: end of 3-day cognitive training vs baselineDescription: cortical excitability measured by transcranial magnetic stimulation (TMS)
Measure: cortical excitability Time: at baselineDescription: quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
Measure: Quality of Life Time: after 1 month vs baselineDescription: memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measure: memory Time: immediately after end of 3-day of cognitive training, after 1 month vs. baselineDescription: affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measure: affective state Time: immediately after the end of 3-day cognitive training, after 1 month vs. baselineDescription: To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).
Measure: genotyping of learning related polymorphisms Time: once15 Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.
NCT02110056 Healthy Older Adults Device: tDCS Behavioral: training
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).. Inclusion Criteria (old healthy controls): - right handedness - unobtrusive neuropsychological screening - age: 50-90 years Exclusion Criteria: - severe internal or psychiatric disease - epilepsy - other severe neurological diseases, e.g. --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to an improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day training period compared to sham stimulation.
Measure: Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS Time: immediately after the end of a 3 day training period in tDCS condition compared to sham conditionSecondary Outcomes
Description: long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition
Measure: long term effects Time: after 1 month vs baselineDescription: Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
Measure: functional changes: Connectivity Time: after end of 3-day period of training vs baselineDescription: measured by transcranial magnetic stimulation (TMS) at baseline
Measure: cortical excitability Time: at baselineDescription: quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
Measure: Quality of life Time: after 1 month vs baselineDescription: memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measure: memory Time: immediately after end of 3-day of cognitive training, after 1 month vs. baselineDescription: affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measure: affective state Time: immediately after the end of 3-day cognitive training, after 1 month vs. baselineDescription: To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).
Measure: genotyping of learning related polymorphisms Time: once16 Modulation of Visual-Spatial Learning in Healthy Young Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine the underlying neuronal mechanism.
NCT02110407 Healthy Young Adults Device: tDCS Behavioral: training
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).. Inclusion Criteria: - right handednesss - unobtrusive neuropsychological screening - age: 18-35 years Exclusion Criteria: - severe internal or psychiatric disease - epilepsy - other severe neurological disease, e.g. --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by the performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
Measure: performance in LOCATO task (visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS Time: immediately after end of a 3 day period of training in tDCS condition vs sham conditionSecondary Outcomes
Description: long term effetcs measured by performance in LOCATO task after end of training and after 1 month compared to control conditions
Measure: long term effects Time: after 1 month vs baselineDescription: Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of training
Measure: functional changes: Connectivity Time: after end of 3-day cognitive training vs baselineDescription: cortical excitability measured by transcranial magnetic stimulation (TMS)
Measure: cortical excitability Time: at baselineDescription: quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
Measure: Quality of Life Time: after 1 month vs baselineDescription: memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measure: memory Time: immediately after end of 3-day of cognitive training, after 1 month vs. baselineDescription: To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).
Measure: genotyping of learning related polymorphisms Time: once17 Neuronal Correlates of Catecholamine Depletion in Patients With Bulimia Nervosa Off Medication and Healthy Controls
Bulimia nervosa is a severe psychiatric disorder characterized by recurrent binge eating episodes followed by inappropriate compensatory behavior to prevent weight gain such as self-induced vomiting. With this project, the investigators want to investigate the role of the neurotransmitter dopamine in bulimia nervosa. Dopamine is reported to have an important influence on the neural reward system and is involved in the processing of gains and losses. The reward system is functionally connected to the individual perception of rewards in the environment. A previous study revealed that under catecholamine depletion including dopamine depletion women suffering from bulimia nervosa in their past reported mild bulimic symptoms and their reward processing became dysfunctional: their ability to use rewarding stimuli for task solving was diminished. The aim of this study is to investigate the role of reduced dopamine availability in the development or maintaining of bulimia nervosa and in the dysfunctional processing of rewarding stimuli and negative visual information. Therefore, the investigators hypothesize that catecholamine depletion achieved by oral administration of alpha-methyl-paratyrosine (AMPT) will induce mild bulimic symptoms in females suffering from bulimia nervosa in their past. In addition, they will reveal dysfunctions in reward and emotional processing under catecholamine depletion. Using functional magnetic resonance imaging, the investigators propose that a reduced activation of the nucleus accumbens, a neural structure of the reward system, will be the neural correlate of this dysfunctional reward processing. Furthermore, the amygdala, a neural structure that is involved in emotional processing, will show a higher activation under catecholamine depletion. Genetic factors additionally have an influence on the dopaminergic system. Therefore, the investigators hypothesize that genetic factors, for example the COMT val-158-met polymorphism may have an effect on the behavioral and neural response to catecholamine depletion. In sum, this investigation may help to understand which changes in reward and emotional processing may lead to a reoccurrence of bulimic symptoms. In future, the findings of this study may help to develop individual pharmacological and psychotherapeutical interventions to enhance the outcome of treatment.
NCT02179814 Bulimia Nervosa Eating Disorders Dopamine Reward Catechol-O-methyltransferase Drug: AMPT/ Demser Drug: Diphenhydramine Drug: Placebo MeSH:Bulimia Feeding and Eating Disorders Bulimia Nervosa
HPO:Bulimia
Therefore, the investigators hypothesize that genetic factors, for example the COMT val-158-met polymorphism may have an effect on the behavioral and neural response to catecholamine depletion. --- val-158-met ---
The COMT val-158-met polymorphism was found to play a critical role for the activity of the enzyme catechol-O-methyltransferase (COMT) that metabolizes catecholamines after they have been released into the synaptic cleft. --- val-158-met ---
In addition this study provided preliminary evidence that COMT val-158-met polymorphism explains some of the variance in the behavioral response to catecholamine depletion. --- val-158-met ---
An additional goal is to examine the effect of the COMT val-158-met polymorphism on neural activity. --- val-158-met ---
3. Participants with homozygous val-158 alleles of the COMT val-158-met polymorphism will show an increased activation in the ventral striatum during a reward task. --- val-158-met ---
4. Participants with at least one met-158 allele of the COMT val-158-met polymorphism will show higher amygdala activation during the encoding of negative emotional visual information. --- val-158-met ---
Primary Outcomes
Measure: Number of participants with side effects Time: 1 yearSecondary Outcomes
Measure: Performance differences in behavioral tasks after catecholamine depletion Time: 4 yearsMeasure: Differences in neural activation assessed during functional magnetic resonance imaging (fMRI) in the different conditions Time: 4 years
Measure: Differences in neural activation assessed during functional magnetic resonance imaging (fMRI) and in performance in behavioral tasks in the different conditions between the different genotypes Time: 4 years
18 The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.
NCT02522988 Fatigue Behavioral: Open-label placebo intervention MeSH:Fatigue
HPO:Fatigue
Test for the presence of a COMT Val158Met/Val or Val/Val variant gene. --- Val158Met ---
Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.. Inclusion Criteria: - Clinical diagnosis of Stage II - IV cancer; - Completed primary treatment 6months to 10 years; - Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale; - Agree not to change any medications or treatments during the study; - Willingness to make 4 clinical site visits over the course of the 49-day study. --- Val158Met ---
Primary Outcomes
Description: Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
Measure: Enrollment Rate Time: End of Study (7 weeks)Description: Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
Measure: Accrual Rate as a Measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number of placebos taken / number prescribed (84)
Measure: Adherence Rate as a Measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number eligible for enrollment / number screened
Measure: Eligibility as a measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled
Measure: Retention as a measure of Acceptability Time: End of Study (7 weeks)Secondary Outcomes
Description: Units of measure: units on a scale using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument. 30-questions measure the global, somatic, affective, behavioral and cognitive manifestations of fatigue. Scale for items = 0 (not at all) - 4 (extremely)
Measure: Measure of fatigue manifestation Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: Unit of measure: units on a scale using the Medical Outcomes Study 36-Item Short Form (MOS-36) instrument. The 36-item instrument measures the impact of fatigue on vitality, physical functioning, emotional functioning, social functioning and mental health. Scale for items = 1 (limited a lot) - 3 (Not limited at all)
Measure: Measurement of impact of fatigue on quality of life Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.
Measure: Measurement of the impact of fatigue on physical function Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: Units of measure: units on a scale using the Fatigue Symptom Inventory (FSI) instrument. Scale = 0 (no fatigue / no interference) to 10 (extreme fatigue / interference)
Measure: Measurement of fatigue severity Time: Baseline, 3 weeks, 4 weeks and 7 weeksOther Outcomes
Description: Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.
Measure: Test for the presence of a COMT Val158Met/Val or Val/Val variant gene Time: Baseline19 Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.
NCT02627664 Parkinson's Disease Other: observational study MeSH:Deglutition Disorders Parkinson Disease Dysarthria
HPO:Dysarthria Dysphagia Oral-pharyngeal dysphagia Spastic dysarthria
To evaluate of cognitive and profile correlation to the polymorphisms of COMT (catechol-O-methyltransferase: Val158Met COMT) of MAPT H1 / H2 (microtubule associated tau protein) and ApoE (Apolipoprotein-E-ε2, 3, 4 ). --- Val158Met ---
Primary Outcomes
Description: BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD
Measure: dysarthria severity assessed by the BECD scale Time: 2 yearsSecondary Outcomes
Description: pulmonary function tests include spirometry with standard spirometer and maximal inspiratory and expiratory flow volume curves . At least 3 reproductible F-V curves are necessary. Values of FCV, FEV, peak expiratory flow, peak inspiratory flow, forced expiratory flow, SNIP were measured 12 hours after last levodopa intake (off drug)
Measure: respiratory insufficiency detection Time: 2 yearsDescription: 150 mL glass of water test video fluoroscopy of swallow in off drug condition face and profile incidences: qualitative analysis of oral, pharyngeal, aspiration if necessary blindly assessed by 2 ENT experts in PD
Measure: swallowing function Time: 2 yearsDescription: SWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)
Measure: gait axial function (freezing) Time: 2 yearsMeasure: Mattis scale Time: 2 years
Measure: LARS scale Time: 2 years
Measure: MADRS scale Time: 2 years
Measure: PAS scale Time: 2 years
Measure: MoCA Time: 2 years
Description: To evaluate of cognitive and profile correlation to the polymorphisms of COMT (catechol-O-methyltransferase: Val158Met COMT) of MAPT H1 / H2 (microtubule associated tau protein) and ApoE (Apolipoprotein-E-ε2, 3, 4 )
Measure: Genetic Polymorphisme Time: 2 years20 Reliability of Pupil Response to Acute Pain
The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.
NCT02628314 Pain Osteoarthritis MeSH:Acute Pain
Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM. --- val158met ---
Primary Outcomes
Description: pupil diameter in response to 5 second presentation of noxious heat stimuli
Measure: Percentage of change in pupil diameter Time: 8 weeksDescription: Verbal pain scores will be obtained during stimulus presentation
Measure: Change from Baseline Verbal Pain Scores Time: 8 weeks21 Improving Learning and School Functioning in Latino Children With Cancer
This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino children with acute leukemia or lymphoblastic lymphoma. A high-intensity intervention program may help doctors to see whether training parents or caregivers in specific parenting skills and "pro-learning" behaviors will result in better learning and school outcomes for Latino children with acute leukemia or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention program is more beneficial than a standard of care lower intensity parenting intervention.
NCT03178617 Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Lymphoblastic Lymphoma Acute Leukemia Other: Educational Intervention Other: Educational Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Non-Hodgkin
HPO:Leukemia Lymphoma Non-Hodgkin lymphoma
EXPLORATORY OBJECTIVES: I. Explore the associations between neurocognitive performance and polymorphisms in candidate genes previously reported to explain cognitive variability in childhood cancer survivors (e.g., the catechol-O-methyltransferase Val158Met polymorphism and the nitric oxide synthase [NOS3] 894T allele) or involved in the stress response (e.g., the Serotonin transporter rs25531 and the Glucocorticoid receptor rs6190). --- Val158Met ---
Primary Outcomes
Description: Measured by the parent-reported Pediatric Quality of Life Inventory school domain.
Measure: Change in child's health-related quality of life school functioning Time: Baseline up to 12 monthsDescription: Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
Measure: Change in parental efficacy Time: Baseline up to 12 monthsSecondary Outcomes
Description: Measured by WIAT: reading and math scores and classroom grades from school report cards.
Measure: Objective academic performance (Child) Time: Up to 12 monthsDescription: Measured by the Conners Parent Report Attention subscale.
Measure: Attention performance (Child) Time: Up to 12 monthsDescription: Measured by PBQ-R3 Behaviors Scale.
Measure: Frequency of pro-learning behaviors (Parent) Time: Up to 12 monthsDescription: Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.
Measure: Frequency of pro-learning behaviors (Parent) Time: Up to 12 monthsDescription: Measured by PBQ-R3 Knowledge scale.
Measure: Knowledge of pro-learning parenting (Parent) Time: Up to 12 monthsMeasure: Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed Time: Up to 12 months
Measure: Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire Time: Up to 12 months
22 Efficacy of Transcranial Direct Current Stimulation for Severe Refractory Primary Dysmenorrhea: Translational and Genetic Neuroimaging Studies
Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. We have previously reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after tDCS intervention. We will recruit 30 severe PDMs and randomly allocate them to either real or sham group in a triple-blind manner. rs-fMRI for functional connectivity analysis will be performed before and after the tDCS intervention. The imaging data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for severe PDM. The result can promise a new possibility for clinical application.
NCT03594916 Primary Dysmenorrhea Device: Active tDCS Device: Sham tDCS MeSH:Dysmenorrhea
HPO:Dysmenorrhea
To genotype the single nucleotide polymorphism genotyping (i.e., BDNF Val66Met polymorphism (rs6265), COMT Val158Met polymorphism (rs4680), OPRM1 (rs1799971), 5HTR2A (rs6313), SLC6A4 (rs25531)) from blood specimen. --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain
Measure: Visual Analog Scale (VAS) Time: change from baseline (1st menstrual phase, before tDCS) at one month (2nd menstrual phase, with tDCS), change from baseline (1st menstrual phase, before tDCS) at two months (3rd menstrual phase)Description: Resting-state functional magnetic resonance imaging (rs-fMRI) is a well established method of functional magnetic resonance imaging (fMRI) that is used to evaluate regional interactions in the brain that occur in a resting (task-negative) state, when a subject is not performing an explicit task. Functional connectivity is the connectivity between brain regions that share functional properties, it can be defined as the correlation between spatially remote neurophysiological events, expressed as the neural networks of brain.
Measure: Functional connectivity of rs-fMRI Imaging Time: change from baseline (before tDCS, before 2nd menstrual phase) at one week (after tDCS completion), change from baseline (before tDCS, before 2nd menstrual phase) at four weeks (before the 3rd menstrual phase)Secondary Outcomes
Description: To assess the threshold of thermal sensation (cold, cold-pain, heat, heat-pain; from 0 to 50 centigrade temperature), according to the established protocol of an ascending limit approach for heat pain and a descending limit approach for cold pain.
Measure: Quantitative sensory testing (QST) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess anxious symptoms; from 20 to 80; score 20: not anxious, score 80: extremely anxious
Measure: Spielberger State-Trait Anxiety Inventory (STAI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess anxious symptoms; from 0 to 63; score 0: not anxious, score 63: extremely anxious
Measure: Beck Anxiety Inventory (BAI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess depressive symptoms; from 0 to 63; score 0: not depressed, score 63: extremely depressed
Measure: Beck Depression Inventory (BDI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess pain-maladaptive psychological status; from 0 to 52; score 0: not pain Catastrophizing , score 52: extremely pain Catastrophizing
Measure: Pain Catastrophizing Scale (PCS) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess pain status; from 0 to 78; score 0: not painful, score 78: extremely painful
Measure: Long-form McGill Pain Questionnaire (MPQ) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess quality of life; he SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. From 0 to 100; score 0: equivalent to maximum disability, score 100: no disability.
Measure: Short-Form Health Survey (SF-36) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess testosterone, progesterone, estrogen
Measure: Blood Hormones Measurement Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)Description: To genotype the single nucleotide polymorphism genotyping (i.e., BDNF Val66Met polymorphism (rs6265), COMT Val158Met polymorphism (rs4680), OPRM1 (rs1799971), 5HTR2A (rs6313), SLC6A4 (rs25531)) from blood specimen
Measure: Genotyping Time: baselineDescription: To assure blinding efficacy; Patients do self-assessment about whether they receive real tDCS or sham tDCS. Assessment questionnaire:1 or 0. 1: real tDCS; 0: sham tDCS.
Measure: Efficacy of tDCS blinding Time: At 1 months after tDCS intervention23 Neuromodulation Effect of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea: BDNF and MEG Study
Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. It has been reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, it is plausible that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of experimental pain after tDCS intervention. Thirty severe PDMs will be recruited and randomly allocated to either real or sham group in a triple-blind manner. Experimental pain electrical stimulation will be performed before and after the tDCS intervention. The experimental pain-evoked magnetoencephamographic (MEG) data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for acute pain in severe PDM. The result can promise a new possibility for clinical application.
NCT03608215 Primary Dysmenorrhea Device: Active tDCS Device: Sham tDCS MeSH:Dysmenorrhea
HPO:Dysmenorrhea
To genotype the single nucleotide polymorphism genotyping (i.e., BDNF Val66Met polymorphism (rs6265), COMT Val158Met polymorphism (rs4680), OPRM1 (rs1799971), 5HTR2A (rs6313), SLC6A4 (rs25531)) from blood specimen. --- Val66Met --- --- Val158Met ---
Primary Outcomes
Description: pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain
Measure: Visual Analog Scale (VAS) Time: change from baseline (1st menstrual phase, before tDCS) at one month (2nd menstrual phase, with tDCS), change from baseline (1st menstrual phase, before tDCS) at two months (3rd menstrual phase)Description: Somatosensory evoked magnetic fields (SEFs) is a well established magnetoencephalographic (MEG) cortical response evoked by electric stimulation. SEFs to experimental pain stimulation using electrical stimulator applied on the skin over the trajectory of median nerve will be used to evaluate pain-evoked cortical response.
Measure: Somatosensory evoked magnetic fields to experimental pain Time: change from baseline (before tDCS, before 2nd menstrual phase) at one week (after tDCS completion), change from baseline (before tDCS, before 2nd menstrual phase) at four weeks (before the 3rd menstrual phase)Secondary Outcomes
Description: To assess the threshold of thermal sensation (cold, cold-pain, heat, heat-pain; from 0 to 50 centigrade temperature), according to the established protocol of an ascending limit approach for heat pain and a descending limit approach for cold pain.
Measure: Quantitative sensory testing (QST) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess anxious symptoms; from 20 to 80; score 20: not anxious, score 80: extremely anxious
Measure: Spielberger State-Trait Anxiety Inventory (STAI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess anxious symptoms; from 0 to 63; score 0: not anxious, score 63: extremely anxious
Measure: Beck Anxiety Inventory (BAI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess depressive symptoms; from 0 to 63; score 0: not depressed, score 63: extremely depressed
Measure: Beck Depression Inventory (BDI) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess pain-maladaptive psychological status; from 0 to 52; score 0: not pain Catastrophizing , score 52: extremely pain Catastrophizing
Measure: Pain Catastrophizing Scale (PCS) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess pain status; from 0 to 78; score 0: not painful, score 78: extremely painful
Measure: Long-form McGill Pain Questionnaire (MPQ) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess quality of life; he SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. From 0 to 100; score 0: equivalent to maximum disability, score 100: no disability.
Measure: Short-Form Health Survey (SF-36) Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)Description: To assess testosterone, progesterone, estrogen
Measure: Blood Hormones Measurement Time: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)Description: To genotype the single nucleotide polymorphism genotyping (i.e., BDNF Val66Met polymorphism (rs6265), COMT Val158Met polymorphism (rs4680), OPRM1 (rs1799971), 5HTR2A (rs6313), SLC6A4 (rs25531)) from blood specimen
Measure: Genotyping Time: baselineDescription: To assure blinding efficacy; Patients do self-assessment about whether they receive real tDCS or sham tDCS. Assessment questionnaire:1 or 0. 1: real tDCS; 0: sham tDCS.
Measure: Efficacy of tDCS blinding Time: At 1 months after tDCS intervention24 The Role of Sex Steroids and Serotonin Brain Dynamics in Perinatal Mental Health
Hormonal transitions such as across pregnancy and postpartum may trigger depressive episodes in some women. It is not known why, but estrogen sensitivity may play a critical role. A preclinical human risk model showed that depressive symptoms induced by pharmacological sex-hormone manipulation is linked to increases in serotonin transporter (SERT) brain binding, which lowers serotonergic brain tone. It is currently unknown if these findings translates to women across pre- to postpartum transitions. This longitudinal project studies a group of women who will deliver by planned caesarian, thus permitting the collection of cerebrospinal fluid (csf) containing central markers of serotonergic signaling, at the latest point in pregnancy. The women are followed across late pregnancy, delivery and 6 months postpartum to illuminate relations between sex-hormones, stress-regulation, estradiol sensitivity, csf markers of neurotransmission, serotonin transporter genotype variance, and potential development of subclinical or manifest depressive symptoms. Further, markers of relevance for the infant brain development and stress-regulation will be obtained from placenta tissue and umbilical cord blood. A subgroup of 70 women will participate in a brain imaging program early postpartum (week 3-5), which includes an evaluation of brain activity and structure and in vivo molecular brain imaging serotonergic markers. Thus, serotonergic markers in csf can be combined with postpartum molecular brain imaging of key features of serotonin signaling. Women in the imaging program are selected based on variation in their level of mental distress immediately postpartum (day 2-5). The study's main hypothesis is that women with high-expressing SERT genotypes are more sensitive to peripartum hormonal transition in terms of changes in serotonergic tone and emergence of depressive symptoms and that such an association will be stronger in the presence of candidate gene transcript biomarkers of oestrogen sensitivity. A further hypothesis is that in vivo molecular brain imaging and csf based serotonergic markers will be associated with depressive symptoms both early and later postpartum. Ideally, this project will provide a rationale for future targeted prevention and/or treatment of perinatal depression in women at high risk, which holds grand potential to protect not only mother but also infant brain health long-term.
NCT03795688 Major Depressive Disorder Perinatal Depression Other: Pregnancy MeSH:Depressive Disorder Depressive Disorder, Major
HPO:Depressivity
val158met (rs4680) status, binary variable, i.e. "val/val, val/met" vs "met/met" variants. --- val158met ---
Primary Outcomes
Description: Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Total group
Measure: Depressive symptoms Time: Week 3-6 postpartumDescription: Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group
Measure: Depressive symptoms Time: Week 3-6 postpartumDescription: 116 a priori defined gene transcripts, which where differentially expressed in third trimester of women who later developed perinatal depression with postpartum onset relative to pregnant women who did not and to other depressed (reference Mehta et al, 2014, Psychological Medicine) and confirmed to be coupled to estrogen fluctuations (Mehtaet al. 2018 British Journal of Psychiatry) will be evaluated in the total group. Also DNA methylation of the genes of these transcripts will be determined and analysed in terms of their predictive value (above chance) for perinatal depression.
Measure: Gene transcript and DNA methylation markers of estrogen sensitivity Time: Prior to caesarean sectionDescription: Latent variable construct of brain 5-HT4R level based on quantification of 5-HT4R binding from 11C-SB207145 positron emission tomography in primary volumes of interest; neocortex, nucleus caudatus, putamen and hippocampus. Assessed in imaging group.
Measure: Cerebral serotonin 4 receptor binding postpartum Time: Week 3-6 postpartumDescription: Assessed in total group
Measure: CSF levels of GABA Time: On day of caesarean sectionDescription: Assessed in total group
Measure: CSF levels of serotonin metabolite (5-HIAA) Time: On day of caesarean sectionDescription: Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.
Measure: Cortisol awakening response Time: Week 3-6 postpartumDescription: Provides an estimate of cortisol exposure up to 6 months prior to delivery, total group
Measure: Hair cortisol level mothers Time: On day of caesarean section.Description: Provides an estimate of fetal cortisol exposure, infants from total group
Measure: Hair cortisol level newborns Time: Day 0-5 postpartum.Description: Hippocampal brain volume (including hippocampus) from structural MRI, imaging group.
Measure: Hippocampal volumes Time: Week 3-6 postpartum.Description: fMRI (BOLD response) based assessment of brain activity in response to reward, relative to non-reward, stimuli. Assessed in imaging cohort
Measure: functional MRI response to reward Time: Week 3-6 postpartum.Description: rsfMRI based spontaneous co-fluctuations in low frequency BOLD signal, (functional connectivity). Assessed with rsfMRI scan in the resting state, i.e. non-goal oriented spontaneous thought and awake. Assessed in imaging group.
Measure: Resting state functional connectivity MRI Time: Week 3-6 postpartumDescription: Change in epigenetic SERT status from late pregnancy to postpartum week 3-6.
Measure: Change in epigenetic SERT status Time: From just before delivery to 3-6 weeks postpartumDescription: Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group
Measure: Concentration of inflammatory markers, i.e hsCRP and immunoactive cytokines, in peripheral blood Time: At week 3-6Description: fMRI (BOLD response) based assessment of brain activity to emotionally salient, relative to neutral, stimuli. Assessed in imaging cohort.
Measure: functional MRI response to emotional faces Time: Week 3-6 postpartum.Secondary Outcomes
Description: Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group
Measure: Depressive symptoms Time: Day 3-5 postpartumDescription: Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group
Measure: Depressive symptoms Time: Week 12 postpartumDescription: Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in total group
Measure: Depressive symptoms Time: Day 3-5 postpartumDescription: Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in all
Measure: Depressive symptoms Time: 6 months postpartumDescription: Assessed in total group
Measure: CSF levels of serotonin Time: On day of caesarean sectionDescription: Assessed in total group
Measure: CSF levels of dopamine metabolites Time: On day of caesarean sectionDescription: Assessed in total group
Measure: CSF levels of noradrenaline metabolites Time: On day of caesarean sectionDescription: Composite measure of IFN-c, IFN-alfa TNF-alfa og IL-6, in total group
Measure: CSF levels of inflammatory markers Time: On day of caesarean sectionDescription: Estradiol level in peripheral blood, total group
Measure: Estradiol level Time: Prior to caesarean section.Description: Estradiol level peripheral blood, total group
Measure: Estradiol level Time: At week 3-6 postpartum.Description: Estradiol change pre- to postpartum, peripheral blood total group
Measure: Change in estradiol level Time: From baseline (caesarean section to week 3-6 postpartum)Description: Progesterone level in peripheral blood
Measure: Progesterone level Time: Prior to caesarean section.Description: Progesterone level in peripheral blood
Measure: Progesterone level Time: At week 3-6 postpartum.Description: Progesterone change pre- to postpartum, peripheral blood total group
Measure: Change in progesterone level Time: From baseline (caesarean section to week 3-6 postpartum)Description: Allopregnanolone level in peripheral blood
Measure: Allopregnanolone level Time: Prior to caesarean section.Description: Allopregnanolone level in peripheral blood
Measure: Allopregnanolone level Time: At week 3-6 postpartum.Description: Change in allopregnanolone level in peripheral blood
Measure: Change in allopregnanolone level Time: From baseline (caesarean section to week 3-6 postpartum)Description: Cortisol change pre- to postpartum, peripheral blood total group
Measure: Change in cortisol level Time: From baseline (caesarean section to week 3-6 postpartum)Description: Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.
Measure: Cortisol awakening response Time: Week 12 postpartumDescription: Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.
Measure: Cortisol awakening response Time: Prior to caesarean sectionDescription: Change in cortisol awakening response, from caesarean section to 3-6 weeks postpartum.
Measure: Change in cortisol awakening response Time: ´From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the SERT gene, total group
Measure: DNA methylation of the SERT gene Time: Prior to caesarean sectionDescription: DNA Methylation status for the SERT gene, total group
Measure: DNA methylation of the SERT gene Time: Week 3-6 postpartumDescription: Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group
Measure: DNA methylation of the FK506-binding protein 51 (FKBP5) gene Time: Prior to caesarean section.Description: Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group
Measure: DNA methylation of the FK506-binding protein 51 (FKBP5) gene Time: Week 3-6 postpartumDescription: Change in methylation status for the FK506-binding protein 51 (FKBP5) gene from late pregnancy to postpartum week 3-6.
Measure: Change in DNA methylation of the FK506-binding protein 51 (FKBP5) gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the glucocorticoid receptor gene, total group
Measure: DNA methylation of the glucocorticoid receptor gene Time: Prior to caesarean section.Description: Methylation status for the glucocorticoid receptor gene, total group
Measure: DNA methylation of the glucocorticoid receptor gene Time: Week 3-6 postpartumDescription: Change in methylation status for the glucocorticoid receptor gene from late pregnancy to postpartum week 3-6.
Measure: Change in DNA methylation of the glucocorticoid receptor gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the COMT gene, total group
Measure: DNA methylation of the COMT gene Time: Prior to caesarean section.Description: Methylation status for the COMT gene, total group
Measure: DNA methylation of the COMT gene Time: Week 3-6 postpartumDescription: Change in methylation status for the COMT gene from just before delivery to 3-6 weeks postpartum
Measure: Change in DNA methylation of the COMT gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the MAO-A gene, total group
Measure: DNA methylation of the MAO-A gene Time: Prior to caesarean section.Description: Change in methylation status for the MAO-A gene, total group
Measure: Change in DNA methylation of the MAO-A gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the MAO-A gene, total group
Measure: DNA methylation of the MAO-A gene Time: Week 3-6 postpartumDescription: Methylation status for the oxytocin receptor gene, total group
Measure: DNA methylation of the oxytocin receptor gene Time: Prior to caesarean section.Description: Methylation status for the oxytocin receptor gene, total group
Measure: DNA methylation of the oxytocin receptor gene Time: Week 3-6 postpartumDescription: Change in methylation status for the oxytocin receptor gene, total group
Measure: Change in DNA methylation of the oxytocin receptor gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Methylation status for the oxytocin gene, total group
Measure: DNA methylation of the oxytocin gene Time: Prior to caesarean section.Description: Methylation status for the oxytocin gene, total group
Measure: DNA methylation of the oxytocin gene Time: Week 3-6 postpartumDescription: Change methylation status for the oxytocin gene, total group
Measure: Change in DNA methylation of the oxytocin gene Time: From baseline (caesarean section to week 3-6 postpartum)Description: Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group
Measure: Systemic inflammation peripheral blood hsCRP and immunoactive cytokines Time: Prior to caesarean section.Description: Change in composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group
Measure: Change in systemic inflammation peripheral blood hsCRP and immunoactive cytokines Time: From baseline (caesarean section to week 3-6 postpartumDescription: Family History Assessment Module (OS-FHAM). Number of first degree relatives with a history of depressive episodes or bipolar disorder. Total group.
Measure: Self reported family history of mood disorders Time: Day 3-5 postpartum or beforeDescription: Barratt Impulsiveness Scale (BIS-11), self-reported. Range: 30-120. Total group.
Measure: Self reported impulsiveness score Time: Day 3-5 postpartum or beforeDescription: NEO-PI-R - Revised NEO Personality Inventory, self-reported. Participants may score 20-80 for each of the personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. The higher the score, the more prominent is the personality trait. Total group.
Measure: Self reported Neuroticism score from NEO personality questionnaire Time: Day 3-5 postpartum or beforeDescription: Parental bonding instrument (PBI), both parents, self-reported. Total group.
Measure: Self reported parental bonding quality Time: Day 3-5 postpartum or beforeDescription: Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.
Measure: Self-reported perceived stress Time: Day 3-5 postpartumDescription: Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.
Measure: Self-reported perceived stress Time: Week 3-6 postpartumDescription: Change in Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.
Measure: Change in self-reported perceived stress Time: Change from day 3-5 to week 3-6 postpartumDescription: Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.
Measure: Self-reported anhedonia Time: Day 3-5 postpartumDescription: Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.
Measure: Self-reported anhedonia Time: Week 3-6 postpartumDescription: Change in Snaith-Hamilton Pleasure Scale (SHAPS) score, range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.
Measure: Change in self-reported anhedonia Time: Change from day 3-5 to week 3-6 postpartumDescription: Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group.
Measure: Self-reported rumination Time: Day 3-5 postpartumDescription: Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group.
Measure: Self-reported rumination Time: Week 3-6 postpartumDescription: Change in Rumination Response Scale (RRS) score, range 22-88, a score of 22 indicates no ruminative symptoms. Total group.
Measure: Change in elf-reported rumination Time: Change from day 3-5 to week 3-6 postpartumDescription: Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group.
Measure: Self-reported mood Time: Day 3-5 postpartumDescription: Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group.
Measure: Self-reported mood Time: Week 3-6 postpartumDescription: Change in Profile of Mood States (POMS) score, range 0-260, a score of 0 indicates no mood disturbance. Total group.
Measure: Change in self-reported mood Time: Change from day 3-5 to week 3-6 postpartumDescription: Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.
Measure: Self-reported sleep quality Time: Day 3-5 postpartumDescription: Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.
Measure: Self-reported sleep quality Time: Week 3-6 postpartumDescription: Change in Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.
Measure: Change in self-reported sleep quality Time: Change from day 3-5 to week 3-6 postpartumDescription: Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group.
Measure: Self-reported psychiatric symptoms Time: Day 3-5 postpartumDescription: Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group.
Measure: Self-reported psychiatric symptoms Time: Week 3-6 postpartumDescription: Change in Brief symptom Inventory-53 item (BSI-53) score, range 0-212, increasing score means worsening of symptoms.Total group.
Measure: Change in self-reported psychiatric symptoms Time: Change from day 3-5 to week 3-6 postpartumDescription: WHO-5 well-being index, range 0-100, low score means less well-being. Total group.
Measure: Self-reported well-being Time: Day 3-5 postpartumDescription: WHO-5 well-being index, range 0-100, low score means less well-being. Total group.
Measure: Self-reported well-being Time: Week 3-6 postpartumDescription: Change in WHO-5 well-being index, range 0-100, low score means less well-being. Total group.
Measure: Change in self-reported well-being Time: Change from day 3-5 to week 3-6 postpartumDescription: State Trait Anxiety Inventory (STAI-AD-D), state and trait subscales each have a range of 20-80, 20 means no anxiety. Total group.
Measure: Self-reported anxiety Time: Day 3-5 postpartumDescription: State Trait Anxiety Inventory (STAI-AD-D), state subscale range 20-80, 20 means no anxiety. Total group.
Measure: Self-reported anxiety Time: Week 3-6 postpartumDescription: Change in State Trait Anxiety Inventory (STAI-AD-D) score, state subscale range 20-80, 20 means no anxiety. Total group.
Measure: Change in self-reported anxiety Time: Change from day 3-5 to week 3-6 postpartumDescription: Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.
Measure: Self-reported obsessive and compulsive symptoms Time: Day 3-5Description: Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.
Measure: Self-reported obsessive and compulsive symptoms Time: Week 3-6 postpartumDescription: Change in Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.
Measure: Change in self-reported obsessive and compulsive symptoms Time: Change from day 3-5 to week 3-6 postpartumDescription: Performance on Simple Reaction Time, in imaging cohort.
Measure: Performance on Simple Reaction Time Time: Week 3-6 postpartumDescription: Gray matter brain volume prefrontal cortex and anterior cingulate cortex
Measure: Gray matter brain volume prefrontal cortex and anterior cingulate cortex Time: At week 3-6 postpartumDescription: Composite measure of serotonin, tryptophan og tryptofan hydroxylase levels relative to 5-HIAA, in placenta sample. Infants from total group
Measure: Serotonergic turnover in placenta Time: At delivery.Description: 11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta. Infants from total group
Measure: 11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta Time: At deliveryDescription: Composite measure of methylation status for the FKBP5, glucocorticoid receptor, 11-beta hydroxysteroid dehydrogenase type 2 genes. Infants from total group
Measure: Methylation status of genes relevant for stress-hormone regulation in placenta Time: At deliveryDescription: Composite measure of the methylation status for monoamine oxidase, serotonin receptor and serotonin transporter genes. Infants from total group
Measure: Methylation status of genes related to serotonergic signaling in placenta Time: At deliveryDescription: Composite measure of methylation status and gene transcript profiles of Glucocorticoid receptor, FKBP5, oxytocin and oxytocin receptors, Brain-derived neurotrophic factor (BDNF) genes. Assessed in blood from umbilical cord blood sample from infants, total group.
Measure: Methylation status and gene transcript profiles of relevance for early brain development and stress regulation in newborn infants Time: At delivery.Other Outcomes
Description: val158met (rs4680) status, binary variable, i.e. "val/val, val/met" vs "met/met" variants
Measure: COMT-genotype (rs4680) variant, i.e met/met vs other polymorphisms Time: Prior to caesarean section.Description: BDNF val66met (rs6265) status, binary variable, i.e. "val/val" versus "met-carrier" status
Measure: BDNF genotype (rs6265) status, i.e. val/val versus met-carrier variants Time: Prior to caesarean section.Description: 5-HTTLPR genotype status (binary), i.e. high-expressing LALA vs low-expressing (S or LG) variants, based on SLC6A4, i.e. L or S variants, and further subtyping on rs25531 haplotype L(A)L(A) vs LGLA, LGLG or variants containing as S as specified above.
Measure: 5-HTT genotype status, i.e LALA vs low-expressing (S or LG) variants Time: Prior to caesarean section.Description: In house interview based on Kennerley Maternity Blues Questionnaire, range: 0-28, higher score indicates more severe postpartum blues symptoms. High blues score is associated with greater risk for perinatal depression at week 3-6.
Measure: Postpartum blues symptoms Time: Day 3-5 postpartum.Description: In house interview based on Stein's Maternity Blues Scale, range 0-26. High blues score is associated with greater risk for perinatal depression at week 3-6.
Measure: Postpartum blues symptoms Time: Day 3-5 postpartum.25 Modulation of Cognitive Flexibility by Transcranial Direct Current Stimulation, Tyrosine Administration and Polymorphisms in the COMT Gene
The current study would examine whether increases in endogenous dopaminergic activity via tyrosine and the (presumed) excitation of these by anodal tDCS of the dlPFC could causally be related to cognitive flexibility as measured by task switching and reversal learning. Additionally, the study will test whether the Val158Met-polymorphism in the catechol- O-methyltransferase (COMT) gene could also predict the effect of TYR supplementation, as this gene is involved in DA degradation in the prefrontal cortex.
NCT03845920 Modulation of Cognitive Flexibility by Transcranial Direct Current Stimulation, Tyrosine Administration and Polymorphisms in the COMT Gene Combination Product: tdcs (sham/anodal) + drug (placebo/tyrosine)
Additionally, the study will test whether the Val158Met-polymorphism in the catechol- O-methyltransferase (COMT) gene could also predict the effect of TYR supplementation, as this gene is involved in DA degradation in the prefrontal cortex. --- Val158Met ---
Primary Outcomes
Description: Measuring change in perseverative errors in the WCST
Measure: Wisconsin Card Sorting Test (WCST) performance Time: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.Description: Measuring change in reversal errors in the WCST
Measure: Probabilistic Reversal Learning (PRL) performance Time: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.Description: Measuring change in conflict cost (defined as the difference in reaction time between congruent and incongruent responses)
Measure: Flanker Task performance Time: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.26 Cognitive Remediation and Supported Education in Psychotic Disorders: a Randomized Controlled Trial on the Efficacy and the Best Predictors of Academic Functioning
This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs. Academic outcomes, cognitive performance as well as psychological and genetic variables will collected at baseline (T0). Participants will then be randomized either to the experimental condition (Cognitive remediation + Supported education + Treatment as usual) or the control condition (Supported education + Treatment as usual) for three months. Directly after the end of treatment (T1) and three months following the end of treatment (T2), the same measures as baseline will be repeated. One year post-treatment (T3), a last assessment will be conducted for academic outcomes.To assess qualitative experience of patients enrolled in supported education, we will recruit a subsample of the randomized controlled trial to participate in a photovoice activity.
NCT04040829 Psychotic Disorders Behavioral: Cognitive remediation therapy (CR) Behavioral: Supported education (SE) Other: Treatment as usual (TAU) MeSH:Mental Disorders Psychotic Disorders
HPO:Psychosis
Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).. Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene. --- Val66Met --- --- Val158Met ---
Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism. --- Val158Met ---
Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene. --- Val158Met ---
Primary Outcomes
Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) Time: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class.
Measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) Time: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)Description: The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve).
Measure: Mean change from baseline on the Rubric tool Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve).
Measure: Mean change from baseline on the Rubric tool Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve).
Measure: Mean change from baseline on the Rubric tool Time: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)Secondary Outcomes
Description: The CVLT-II assesses verbal episodic memory. The test includes the learning of a list of words, followed by an immediate and a delayed recall.
Measure: Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall). Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The CVLT-II assesses verbal episodic memory. The test includes the learning of a list of words, followed by an immediate and a delayed recall.
Measure: Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall). Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Rey complex figure test assesses visual episodic memory. The test includes the copy of a complex figure, followed by an immediate and a delayed recall.
Measure: Raw score change from baseline on the Rey Complex Figure test (delayed recall). Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Rey complex figure test assesses visual episodic memory. The test includes the copy of a complex figure, followed by an immediate and a delayed recall.
Measure: Raw score change from baseline on the Rey Complex Figure test (delayed recall). Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The digit span subtest backward assesses verbal working memory. A series of number are read to the participant. The participant has to recall the numbers backward.
Measure: Raw score change from baseline on the digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The digit span subtest backward assesses verbal working memory. A series of number are read to the participant. The participant has to recall the numbers backward.
Measure: Raw score change from baseline on the digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
Measure: Raw score change from baseline on the coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
Measure: Raw score change from baseline on the coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The spatial span subtest backward assesses visual working memory. A board with blocks are presented to the participant. The assessor point series of blocks and the participant has to point the blocks backward.
Measure: Raw score change from baseline on the spatial span subtest backward of the Wechsler Memory Scale Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The spatial span subtest backward assesses visual working memory. A board with blocks are presented to the participant. The assessor point series of blocks and the participant has to point the blocks backward.
Measure: Raw score change from baseline on the spatial span subtest backward of the Wechsler Memory Scale Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The HRT-BC assesses sustained attention. Letters appear on a computer screen and the participant has to press the space bar as fast as possible, except when the letter is an "X". The HRT-BC reflects the reaction time between the six conditions of the CPT-3. In each condition, the letters are presented at a different rate. A higher HRT-BC score indicates a decrease of efficiency in information processing, which suggest difficulties in sustained attention.
Measure: Raw score change from baseline on the Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The HRT-BC assesses sustained attention. Letters appear on a computer screen and the participant has to press the space bar as fast as possible, except when the letter is an "X". The HRT-BC reflects the reaction time between the six conditions of the CPT-3. In each condition, the letters are presented at a different rate. A higher HRT-BC score indicates a decrease of efficiency in information processing, which suggest difficulties in sustained attention.
Measure: Raw score change from baseline on the Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The fourth condition of the Trail Making Test assesses cognitive flexibility. Letters and numbers are presented on a page.The participants has to connect these letters in alphabetical order and the numbers in numerical order while alternating between the numbers and letters
Measure: Raw score change from baseline on the fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The fourth condition of the Trail Making Test assesses cognitive flexibility. Letters and numbers are presented on a page.The participants has to connect these letters in alphabetical order and the numbers in numerical order while alternating between the numbers and letters
Measure: Raw score change from baseline on the fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The third condition of the color-word interference assesses inhibition. Name of color written in a different color of ink are presented to the participant. The participant has to name the color of the ink for each word as fast as possible.
Measure: Raw score change from baseline on the third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The third condition of the color-word interference assesses inhibition. Name of color written in a different color of ink are presented to the participant. The participant has to name the color of the ink for each word as fast as possible.
Measure: Raw score change from baseline on the third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The first condition of the verbal fluency subtest assesses phonemic fluency. The participant has to name as many word as possible in one minute that start by a given letter.
Measure: Raw score change from baseline on the verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The first condition of the verbal fluency subtest assesses phonemic fluency. The participant has to name as many word as possible in one minute that start by a given letter.
Measure: Raw score change from baseline on the verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Tower of London assesses planning and organization. For this test, the assessor produces different models on his board using three beads (green, blue and red). The participant has to replicate the model using as few moves as possible.
Measure: Raw score change from baseline on the Tower of London (total item completed with the minimum movement) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Tower of London assesses planning and organization. For this test, the assessor produces different models on his board using three beads (green, blue and red). The participant has to replicate the model using as few moves as possible.
Measure: Raw score change from baseline on the Tower of London (total item completed with the minimum movement) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Matrix reasoning subtest assesses perceptual reasoning. Series of complex patterns are presented to the participant. The participant has to choose the logical end to each pattern.
Measure: Raw score change from baseline on the Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Matrix reasoning subtest assesses perceptual reasoning. Series of complex patterns are presented to the participant. The participant has to choose the logical end to each pattern.
Measure: Raw score change from baseline on the Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Combined stories test assesses theory of mind. Short stories are presented to the participant and questions regarding the mental states of the characters are asked.
Measure: Raw score change from baseline on the Combined Stories test Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Combined stories test assesses theory of mind. Short stories are presented to the participant and questions regarding the mental states of the characters are asked.
Measure: Raw score change from baseline on the Combined Stories test Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Social Knowledge test assess social perception. Situations of daily life are presented to the participant. The participant is asked to state the emotion that would be felt by most people in that situation.
Measure: Raw score change from baseline on the Social Knowledge test Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Social Knowledge test assess social perception. Situations of daily life are presented to the participant. The participant is asked to state the emotion that would be felt by most people in that situation.
Measure: Raw score change from baseline on the Social Knowledge test Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Penn Emotion Recognition task assesses emotion recognition. Faces expressing emotions are presented on a computer screen. The participant has to determine the emotion expressed by the character among the seven choices.
Measure: Raw score change from baseline on the Penn Emotion Recognition task Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Penn Emotion Recognition task assesses emotion recognition. Faces expressing emotions are presented on a computer screen. The participant has to determine the emotion expressed by the character among the seven choices.
Measure: Raw score change from baseline on the Penn Emotion Recognition task Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The Échelle de Répercussion Fonctionnelle assesses functional impact of cognitive deficits in daily living using a semi-structured interview. The severity of the functional impact is rated on a Likert scale from 1= no impact to 7=important impact.
Measure: Raw score change from baseline on the Échelle de Répercussion Fonctionnelle Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The Échelle de Répercussion Fonctionnelle assesses functional impact of cognitive deficits in daily living using a semi-structured interview. The severity of the functional impact is rated on a Likert scale from 1= no impact to 7=important impact.
Measure: Raw score change from baseline on the Échelle de Répercussion Fonctionnelle Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
Measure: Raw score change from baseline on the Positive And Negative Syndrome Scale (PANSS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
Measure: Raw score change from baseline on the Positive And Negative Syndrome Scale (PANSS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
Measure: Raw score change from baseline on the Self-Esteem Rating Scale (SERS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
Measure: Raw score change from baseline on the Self-Esteem Rating Scale (SERS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The SSTICS assesses metacognitive knowledge, i.e., participant' perceptions of his cognitive abilities. The questionnaire includes 21 questions rated on a Likert scale ranging from 0=Never to 4=very often.
Measure: Raw score change from baseline on the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The SSTICS assesses metacognitive knowledge, i.e., participant' perceptions of his cognitive abilities. The questionnaire includes 21 questions rated on a Likert scale ranging from 0=Never to 4=very often.
Measure: Raw score change from baseline on the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree
Measure: Raw score change from baseline on the First-Episode Social Functioning Scale (FESFS) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree
Measure: Raw score change from baseline on the First-Episode Social Functioning Scale (FESFS) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: The CTQ assesses adverse events experienced during childhood and adolescence. The CTQ includes 70 items rated on a Likert scale ranging from 1=Never true to 5=very often true
Measure: Raw score change from baseline on the Childhood Trauma Questionnaire (CTQ) Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: The CTQ assesses adverse events experienced during childhood and adolescence. The CTQ includes 70 items rated on a Likert scale ranging from 1=Never true to 5=very often true
Measure: Raw score change from baseline on the Childhood Trauma Questionnaire (CTQ) Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).
Measure: Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).
Measure: Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)Description: Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Measure: Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene Time: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)Description: Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Measure: Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene Time: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)