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D002659: Child Development Disorders, Pervasive

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (16)


Name (Synonyms) Correlation
drug648 COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki 0.63
drug635 COVID-19 FACILITY Wiki 0.45
drug2527 Placebo Infusion Wiki 0.45
Name (Synonyms) Correlation
drug2777 RO6953958 Wiki 0.45
drug3949 lung ultrasound Wiki 0.45
drug2712 Pulse Oximeter Wiki 0.45
drug985 Daily Monitoring Wiki 0.45
drug639 COVID-19 PCR Swab Wiki 0.45
drug919 Cord Tissue Mesenchymal Stromal Cells Wiki 0.45
drug725 Cannabidivarin Wiki 0.45
drug1183 Emotional Support Plan Wiki 0.45
drug3705 Wearable Medical Device (Empatica E4) Wiki 0.45
drug1714 Interview by psychologists Wiki 0.45
drug1974 Matched Placebo Wiki 0.32
drug644 COVID-19 RT-PCR Wiki 0.26
drug2505 Placebo Wiki 0.02

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D001321 Autistic Disorder NIH 0.75
D000067877 Autism Spectrum Disorder NIH 0.67
D065886 Neurodevelopmental Disorders NIH 0.32
Name (Synonyms) Correlation
D006948 Hyperkinesis NIH 0.32
D002658 Developmental Disabilities NIH 0.26
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.22
D004194 Disease NIH 0.21
D001523 Mental Disorders NIH 0.09
D013315 Stress, Psychological NIH 0.09

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000717 Autism HPO 0.75
HP:0000729 Autistic behavior HPO 0.67
HP:0002487 Hyperkinetic movements HPO 0.32
Name (Synonyms) Correlation
HP:0007018 Attention deficit hyperactivity disorder HPO 0.22

Clinical Trials

Navigate: Correlations   HPO

There are 5 clinical trials


1 Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

NCT03202303
Conditions
  1. Autism Spectrum Disorder
Interventions
  1. Drug: Cannabidivarin
  2. Drug: Matched Placebo
MeSH:Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Autism Autistic behavior

Primary Outcomes

Description: Change in ABC-I from Baseline to Endpoint

Measure: Aberrant Behavior Checklist-Irritability Subscale (ABC-I)

Time: Change in ABC-I from Baseline to Week 12 (Change over 12 weeks)

Secondary Outcomes

Description: Change in RBS-R from Baseline to Endpoint

Measure: Repetitive Behavior Scale-Revised (RBS-R)

Time: Change in RBS-R from Baseline to Week 12 (Change over 12 weeks)

Description: Change in ABC-SW from Baseline to Endpoint

Measure: Aberrant Behavior Checklist-Social Withdrawal Subscale (ABC-SW)

Time: Change in ABC-SW from Baseline to Week 12 (Change over 12 weeks)

Description: Change in PedsQL from Baseline to Endpoint

Measure: Pediatric Quality of Life Inventory (PedsQL) Family Impact Module

Time: Change in PedsQL from Baseline to Week 12 (Change over 12 weeks)

Description: Change in Vineland-3 from Baseline to Endpoint

Measure: Vineland Adaptive Behavior Scale-3 (Vineland 3)

Time: Change in Vineland-3 from Baseline to Week 12 (Change over 12 weeks)

Description: Change in CGI-I from Baseline to Endpoint

Measure: Clinical Global Impressions-Improvement (CGI-I)

Time: Change in CGI-I from Baseline to Week 12 (Change over 12 weeks)

Description: The MERS-R is designed to assess three domains of rigid behavior in children and adults with ASD: 1. Behavioral Rigidity (e.g., insistence on sameness, things must be done in his/her way, etc.) 2. Cognitive Rigidity (e.g., special interests, inflexible adherence to rules, etc.) 3. Protest (in response to deviation from rigidity; e.g., verbal objection, tantrum, physical aggression).

Measure: Montefiore Einstein Rigidity Scale-Revised (MERS-R)

Time: Change in MERS-R from Baseline to Week 12 (Change over 12 weeks)
2 A Phase II Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Children With Autism Spectrum Disorder

The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).

NCT04089579
Conditions
  1. Autism
  2. Autism Spectrum Disorder
Interventions
  1. Biological: Cord Tissue Mesenchymal Stromal Cells
  2. Other: Placebo Infusion
MeSH:Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Autism Autistic behavior

Primary Outcomes

Description: The primary outcome measure is the mean of the change on the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3). The primary endpoint is the change on this outcome measure from baseline to six months.

Measure: Change on the Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales

Time: Baseline, 6 months

Secondary Outcomes

Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score

Measure: Change in VABS-3 Socialization Standard Score

Time: Baseline, 6 months

Description: Change in VABS-3 (Vineland Adaptive Behavior Scales) Communication Standard Score

Measure: Change in VABS-3 Communication Standard Score

Time: Baseline, 6 months

Description: Clinical Global Impression- Severity Scale

Measure: Change in CGI-Severity score

Time: Baseline, 6 months

Description: Clinical Global Impression- Impression

Measure: CGI-Intervention score

Time: Baseline, 6 months

Description: Pediatric Quality of Life Scale

Measure: Change in the Pediatric Quality of Life Scale

Time: Baseline, 6 months

Other Outcomes

Description: Assess for infusion reactions

Measure: Incidence and severity of infusion reactions

Time: Baseline, 6 months

Description: Assess for infections directly related to the study product infusions

Measure: Incidence and severity of product-related infections

Time: Baseline, 6 months

Description: Assess for anti-HLA antibodies

Measure: Evidence of formation of anti-HLA antibodies

Time: Baseline, 6 months, 12 months

Description: Assess for signs and symptoms of graft versus host disease

Measure: Incidence and severity of graft versus host disease

Time: 6 months, 12 months

Description: Assess for study related and unexpected adverse events

Measure: Incidence and severity of unexpected adverse events related to the study product

Time: Baseline, 6 months, 12 months
3 Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).

NCT04416360
Conditions
  1. Autism Spectrum Disorder
  2. Attention-deficit Hyperactivity Disorder
Interventions
  1. Other: Interview by psychologists
MeSH:Hyperkinesis Disease Autistic Disorder Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Attention deficit hyperactivity disorder Autism Autistic behavior Hyperactivity Hyperkinetic movements

Primary Outcomes

Description: composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.

Measure: Interview of the parents : contextual data

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 1 month

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 3 months

Description: Data relating to disease and management of care. Experience of the referring caregiver.

Measure: Interview of the referring caregiver : data relating to disease and management of care

Time: 3 months
4 ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).

NCT04460677
Conditions
  1. Psychological Distress
  2. Stress, Psychological
  3. Autism Spectrum Disorder
Interventions
  1. Behavioral: Emotional Support Plan
  2. Behavioral: Daily Monitoring
MeSH:Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Stress, Psychological
HPO:Autism Autistic behavior

Primary Outcomes

Description: The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.

Measure: Decreased distress on Patient Health Questionnaire (PHQ-9)

Time: 8 week study period

Description: EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.

Measure: Decreased distress on EMA reports

Time: 8 week study period

Description: The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.

Measure: Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

Time: 8 week study period

Secondary Outcomes

Description: The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.

Measure: Adult Self Report (ASR)

Time: 8 week study period
5 A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 Following Oral Administration in Healthy Male Participants

This study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.

NCT04475848
Conditions
  1. Autistic Disorder
  2. Autism Spectrum Disorder
  3. Child Development Disorders, Pervasive
  4. Mental Disorders
  5. Neurodevelopmental Disorders
Interventions
  1. Drug: RO6953958
  2. Drug: Placebo
MeSH:Disease Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Neurodevelopmental Disorders Developmental Disabilities
HPO:Autism Autistic behavior

Primary Outcomes

Measure: Percentage of Participants with Adverse Events in Part 1

Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)

Measure: Percentage of Participants with Adverse Events in Part 2

Time: From randomization up to 8 weeks

Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

Time: From randomization up to 8 weeks

Secondary Outcomes

Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: CL/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: V/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Ae of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Fe of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: CLR of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

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