Covid 19 Research using Clinical Trials (Home Page)
Report for D006948: Hyperkinesis NIH
(Synonyms: Hyperki, Hyperkines, Hyperkinesis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug540 | Certified cloth face mask plus preventive information Wiki | 0.71 |
| drug1017 | Guanfacine hydrochloride (SPD503) Wiki | 0.71 |
| drug1244 | Interview by psychologists Wiki | 0.71 |
| drug1906 | Preventive information Wiki | 0.71 |
| drug539 | Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies Wiki | 0.71 |
| drug236 | Atomoxetine hydrochloride Wiki | 0.71 |
| drug1822 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity NIH | 0.71 |
| D002659 | Child Development Disorders, Pervasive NIH | 0.41 |
| D001321 | Autistic Disorder NIH | 0.35 |
| D000067877 | Autism Spectrum Disorder NIH | 0.29 |
| D004194 | Disease NIH | 0.13 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002487 | Hyperkinetic movements HPO | 1.00 |
| HP:0007018 | Attention deficit hyperactivity disorder HPO | 0.71 |
| HP:0000717 | Autism HPO | 0.35 |
| HP:0000729 | Autistic behavior HPO | 0.29 |
There are 2 clinical trials
Clinical Trials
1 A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder
This interventional multicenter dose-optimization Phase IV PASS conducted in Europe and the USA evaluates the comparative long-term safety and efficacy of SPD503 in children and adolescents aged 6 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) for whom stimulants are not suitable, not tolerated, or shown to be ineffective. The study will be conducted in two parts: Study Part A (randomized, double-blinded, parallel-group, placebo- and active comparator-controlled, 3-treatment arm safety and efficacy evaluation of SPD503) and Study Part B (open label SPD503 treatment).
NCT04085172 Attention Deficit Hyperactivity Disorder (ADHD) Drug: Guanfacine hydrochloride (SPD503) Drug: Atomoxetine hydrochloride Other: Placebo MeSH:Hyperkinesis Attention Deficit Disorder with Hyperactivity
HPO:Attention deficit hyperactivity disorder Hyperactivity Hyperkinetic movements
Primary Outcomes
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 10 in both Part A and Part B of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10 Time: Baseline, Week 10
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 18 in Part A of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18 Time: Baseline, Week 18
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 49 in both Part A and Part B of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49 Time: Baseline, Week 49
Secondary Outcomes
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Cognitive domain, sustained attention will be measured by the CANTAB RVP task. RVP measures the ability to sustain attention over time and is a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo--random order at a rate of 100 digits per minute in a box at the center of the screen. Participants are to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen.
Measure: Change from Baseline in the Rapid Visual Information Processing (RVP) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments, SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategize heuristically. The test is a sensitive measure of frontal lobe and executive dysfunction.
Measure: Change from Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments.Response control or inhibition cognitive domain will be measured by the CANTAB SST. SST measure response inhibition. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone is present, the participant is not to respond.
Measure: Change from Baseline in the Stop Signal Task (SST) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Recognition memory of cognition domain will be measured by the CANTAB DMS task. DMS measures both simultaneous matching and short-term visual memory. The participant is shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample.
Measure: Change from Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49
Description: Sexual maturation will be measured by Tanner stage. The stage of puberty or sexual maturation will be evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) will be documented at the specified times.
Measure: Tanner Stage in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49
Description: Physical examinations will include height and weight. Growth will be measured by weight, height, and BMI. Body mass index is a measure of body fat based on height and weight. Vital signs will be assessed based on blood pressure, pulse rate, respiratory rate and body temperature in both Part A and Part B. The HR, PR interval, QRS interval, and QT interval will be measured from all ECGs and the QTcB and QTcF assessed at specified time points in both Part A and Part B of the study.
Measure: Number of participants with clinically significant changes in Vital signs, ECG, Physical Examination Time: From start of study drug administration up to follow up (week 52)
Description: Psychiatric symptoms will be measured by the Brief Psychiatric Rating Scale for Children (BPRS-C) total score. The 21 items of the clinician-rated BPRS-C are grouped into the following 7 scales: depression, anxiety, psychomotor excitation, behavior problems, withdrawal retardation, thinking disturbance, and organicity. Each item of the 21 items is clinician-graded using the following 7-point severity Likert-scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6. BPRS-C will be assessed at specified time points in both Part A and Part B.
Measure: Brief Psychiatric Rating Scale for Children (BPRS-C) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
Description: The C-SSRS is a structured tool to assess suicidal ideation and behavior. A maximum of 19 items will be completed as follows: 7 items are required, a potential 10 additional items will be completed upon a positive response to a required item, and 2 items completed if suicide or suicide-like behavior is observed during the interview. The C-SSRS uses dichotomous scales (i e, yes or no), Likert scales, and text or narrative to further describe thoughts or behaviors. C-SSRS Score will be assessed at specified time points in both Part A and Part B.
Measure: Columbia- Suicide Severity Rating Scale (CSSRS) Time: Baseline (from start of study drug administration) to Week 52
Description: UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of SPD503 such as Increased Duration of Sleep, Asthenia or Lassitude or lncreased Fatigability, Sleepiness or Sedation, and Orthostatic Dizziness. UKU rating scale will be assessed at specified time points in both Part A and Part B.
Measure: Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52 Part B: Baseline, Week 10, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52
Description: Sedative effects will be measured by participant ratings on the Pediatric Daytime Sleepiness Scale (PDSS). The PDSS is a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions are based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions are scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS can range from 0 (never sleepy) to 32 (always sleepy). PDSS will be assessed at specified time points in both Part A and Part B.
Measure: Pediatric Daytime Sleepiness Scale (PDSS) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
Description: The ADHD-RS-5 (DuPaul et al., 2016) is used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. Attention-deficit/hyperactivity disorder symptoms is measured by the investigator-administered ADHD Rating Scale-5 (ADHD-RS-5) total score and hyperactivity/impulsivity and inattentiveness symptoms as subscale scores. The ADHD-RS-5 is based on the diagnostic criteria for ADHD as described in the DSM-5 and consists of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale is scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The total score can range from 0 to 54. ADHD-RS-5 Total Score and Subscales wiil be assessed at specified time points in both Part A and Part B.
Measure: ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales Time: Part A: Baseline, Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
Description: Global clinical measurement of ADHD improvement as measured by Clinical Global Impression-Improvement (CGI-I) using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI scale will be used to evaluate the severity of mental illness over time. The CGI-S will be administered to assess the severity of mental illness at baseline. The CGI-S is scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-I is also scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I will be measured at specified time points in both Part A and Part B.
Measure: Clinical Global Impression-Improvement (CGI-I) Time: Part A: Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Week 10, Week 23, Week 36 and Week 49
Description: The Parent Report Form of the Child Health and Illness Profile - Child Edition (CHIP-CE:PRF) will be administered to provide information on self-esteem and school functioning in pediatric participants diagnosed with ADHD. The 5 domains and 12 subdomains covered in the 76 items comprising the CHIP-CE:PRF. Satisfaction: with health (7 items) and self (4 items); Comfort: physical (9 items) and emotional symptoms (9 items) and activity restrictions (4 items) due to illness; Resilience: behaviors and family involvement (8 items) in activities likely to enhance health, Social problem-solving (5 items),Physical activity (6 items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4 items), Threats to achievement (10 items); Achievement: developmentally appropriate role functioning in school and with peers: Academic performance (5 items), Peer relations (5 items). CHIP-CE: PRF will be assessed in both Part A and Part B.
Measure: Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
Description: School performance will be measured by teacher ratings of academic skills using the APRS at specified time points in both Part A and Part B. The APRS is a reliable rating scale that has been shown to be valid in assessing teacher perceptions of the quality of a student's academic competency. The scale includes 19 items that are directed toward work performance in various participant areas; academic success, behavioral control in academic situations, and attention to assignments. Teachers mark responses in a Likert-scale format from 1 (never or poor) to 5 (very often or excellent). From the APRS, a total score and the following 3 subscale scores are calculated: academic success, impulse control, and academic productivity.
Measure: Academic Performance Rating Scale (APRS) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
2 Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak
Primary Outcomes
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 10 in both Part A and Part B of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10 Time: Baseline, Week 10Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 18 in Part A of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18 Time: Baseline, Week 18Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 49 in both Part A and Part B of the study.
Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49 Time: Baseline, Week 49Secondary Outcomes
Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Cognitive domain, sustained attention will be measured by the CANTAB RVP task. RVP measures the ability to sustain attention over time and is a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo--random order at a rate of 100 digits per minute in a box at the center of the screen. Participants are to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen.
Measure: Change from Baseline in the Rapid Visual Information Processing (RVP) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments, SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategize heuristically. The test is a sensitive measure of frontal lobe and executive dysfunction.
Measure: Change from Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments.Response control or inhibition cognitive domain will be measured by the CANTAB SST. SST measure response inhibition. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone is present, the participant is not to respond.
Measure: Change from Baseline in the Stop Signal Task (SST) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Recognition memory of cognition domain will be measured by the CANTAB DMS task. DMS measures both simultaneous matching and short-term visual memory. The participant is shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample.
Measure: Change from Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49Description: Sexual maturation will be measured by Tanner stage. The stage of puberty or sexual maturation will be evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) will be documented at the specified times.
Measure: Tanner Stage in Both Part A and Part B at Specified Time Points Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49Description: Physical examinations will include height and weight. Growth will be measured by weight, height, and BMI. Body mass index is a measure of body fat based on height and weight. Vital signs will be assessed based on blood pressure, pulse rate, respiratory rate and body temperature in both Part A and Part B. The HR, PR interval, QRS interval, and QT interval will be measured from all ECGs and the QTcB and QTcF assessed at specified time points in both Part A and Part B of the study.
Measure: Number of participants with clinically significant changes in Vital signs, ECG, Physical Examination Time: From start of study drug administration up to follow up (week 52)Description: Psychiatric symptoms will be measured by the Brief Psychiatric Rating Scale for Children (BPRS-C) total score. The 21 items of the clinician-rated BPRS-C are grouped into the following 7 scales: depression, anxiety, psychomotor excitation, behavior problems, withdrawal retardation, thinking disturbance, and organicity. Each item of the 21 items is clinician-graded using the following 7-point severity Likert-scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6. BPRS-C will be assessed at specified time points in both Part A and Part B.
Measure: Brief Psychiatric Rating Scale for Children (BPRS-C) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49Description: The C-SSRS is a structured tool to assess suicidal ideation and behavior. A maximum of 19 items will be completed as follows: 7 items are required, a potential 10 additional items will be completed upon a positive response to a required item, and 2 items completed if suicide or suicide-like behavior is observed during the interview. The C-SSRS uses dichotomous scales (i e, yes or no), Likert scales, and text or narrative to further describe thoughts or behaviors. C-SSRS Score will be assessed at specified time points in both Part A and Part B.
Measure: Columbia- Suicide Severity Rating Scale (CSSRS) Time: Baseline (from start of study drug administration) to Week 52Description: UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of SPD503 such as Increased Duration of Sleep, Asthenia or Lassitude or lncreased Fatigability, Sleepiness or Sedation, and Orthostatic Dizziness. UKU rating scale will be assessed at specified time points in both Part A and Part B.
Measure: Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52 Part B: Baseline, Week 10, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52Description: Sedative effects will be measured by participant ratings on the Pediatric Daytime Sleepiness Scale (PDSS). The PDSS is a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions are based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions are scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS can range from 0 (never sleepy) to 32 (always sleepy). PDSS will be assessed at specified time points in both Part A and Part B.
Measure: Pediatric Daytime Sleepiness Scale (PDSS) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49Description: The ADHD-RS-5 (DuPaul et al., 2016) is used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. Attention-deficit/hyperactivity disorder symptoms is measured by the investigator-administered ADHD Rating Scale-5 (ADHD-RS-5) total score and hyperactivity/impulsivity and inattentiveness symptoms as subscale scores. The ADHD-RS-5 is based on the diagnostic criteria for ADHD as described in the DSM-5 and consists of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale is scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The total score can range from 0 to 54. ADHD-RS-5 Total Score and Subscales wiil be assessed at specified time points in both Part A and Part B.
Measure: ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales Time: Part A: Baseline, Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49Description: Global clinical measurement of ADHD improvement as measured by Clinical Global Impression-Improvement (CGI-I) using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI scale will be used to evaluate the severity of mental illness over time. The CGI-S will be administered to assess the severity of mental illness at baseline. The CGI-S is scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-I is also scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I will be measured at specified time points in both Part A and Part B.
Measure: Clinical Global Impression-Improvement (CGI-I) Time: Part A: Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Week 10, Week 23, Week 36 and Week 49Description: The Parent Report Form of the Child Health and Illness Profile - Child Edition (CHIP-CE:PRF) will be administered to provide information on self-esteem and school functioning in pediatric participants diagnosed with ADHD. The 5 domains and 12 subdomains covered in the 76 items comprising the CHIP-CE:PRF. Satisfaction: with health (7 items) and self (4 items); Comfort: physical (9 items) and emotional symptoms (9 items) and activity restrictions (4 items) due to illness; Resilience: behaviors and family involvement (8 items) in activities likely to enhance health, Social problem-solving (5 items),Physical activity (6 items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4 items), Threats to achievement (10 items); Achievement: developmentally appropriate role functioning in school and with peers: Academic performance (5 items), Peer relations (5 items). CHIP-CE: PRF will be assessed in both Part A and Part B.
Measure: Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49Description: School performance will be measured by teacher ratings of academic skills using the APRS at specified time points in both Part A and Part B. The APRS is a reliable rating scale that has been shown to be valid in assessing teacher perceptions of the quality of a student's academic competency. The scale includes 19 items that are directed toward work performance in various participant areas; academic success, behavioral control in academic situations, and attention to assignments. Teachers mark responses in a Likert-scale format from 1 (never or poor) to 5 (very often or excellent). From the APRS, a total score and the following 3 subscale scores are calculated: academic success, impulse control, and academic productivity.
Measure: Academic Performance Rating Scale (APRS) Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49In 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 Autism Spectrum Disorder Attention-deficit Hyperactivity Disorder 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
HPO Nodes
HP:0002487: Hyperkinetic movements
Genes 29
NEUROD2 GNE RTTN SUCLA2 NGLY1 GCH1 PDE10A SLC9A6 GNAO1 SYT1 ZNF142 NGLY1 PSAP TRAPPC11 SYT1 TRAPPC11 CACNA1B IQSEC2 ALDH5A1 GRIN1 THOC2 SLC6A3 PYCR2 PNKD PRRT2 CACNA1E FRRS1L PTS YME1L1 Protein Mutations 1
T380A SNP 0
HP:0000752: Hyperactivity
Genes 476
PPM1D DRD4 NKX2-1 SLC1A4 SLC6A8 LIMK1 HTT CLCN4 LMAN2L TSC2 STS SGSH SLC13A5 EPCAM KIF11 ELN CNKSR2 UPF3B GABRG2 GABRB3 DRD5 SLC1A2 PWAR1 CLTC ATR ADSL MED13L SETBP1 CHD2 PNP GNAQ RAB39B TSC1 SCN8A FGFR3 PUS7 DPYD SCN8A ARHGEF6 TBX1 SYNJ1 DYRK1A WWOX NFIX CHRNA7 MLH3 GNB5 TRAK1 MSH2 KANSL1 SHOC2 EP300 ARX TRIP12 IL1RAPL1 DYNC1I2 SHANK3 GABRA2 KMT2A SLC25A22 ZC3H14 CLIP1 RAI1 ANK3 MTOR PIGQ FGD1 GATAD2B PIEZO2 FLI1 GABRG2 CACNA1B ANK3 CNKSR2 C12ORF4 AFF2 YWHAG NTNG2 RAD21 MCTP2 HGSNAT DDX3X ARVCF FBXO31 FLCN RPS6KA3 MED25 MID2 ATRX RERE UQCC2 KDM6B NDN MAPK1 STS CUX2 MBOAT7 TRAPPC9 FBXO11 IQSEC2 ASPM HDC MED13 TAF1 MED23 TSPAN7 RAI1 ALKBH8 IL1RAPL1 BCAP31 OCRL ZSWIM6 EBP NEXMIF DPP6 EEF1A2 PNKP MAGEL2 KCNB1 SMC1A GTF2IRD1 UFD1 SNORD115-1 MED12 CACNA1A GAMT PIGY SH2B1 RFC2 DMXL2 GABRG2 MID2 CORO1A PRKCG FOXP1 DPF2 EP300 NSDHL CLTC FRMPD4 KIF14 DEAF1 SPG7 CC2D1A SIN3A SNRPN CLIP2 LNPK COMT NECAP1 GABRA1 SZT2 OPHN1 PIGP JMJD1C TCF20 AARS1 FRRS1L WDR62 UBA5 SOX5 TTI2 NOP56 PRSS12 PCGF2 TSHR KDM5B AUTS2 HIRA BCR IQSEC2 YWHAG TBX1 PGAP1 STAG2 NSUN2 MSH6 PMS1 CREBBP GNAO1 MAN1B1 PRODH DNAJC21 RSRC1 ASH1L PARS2 ZNF41 ST3GAL3 IQSEC1 CXORF56 RERE CIC KCNA2 ZNF711 TRIO ELN RAB39B KCNK9 MED12 FGD1 PPP2R1A GATA4 SYP CSNK2A1 GDI1 KCNA1 NTRK1 SETD5 SLC9A7 PCDH19 CDKL5 TBX1 TUSC3 POLA1 PWRN1 MED12 RPS20 USP7 KMT2A HUWE1 AIMP1 TUBB2B SATB2 FGF12 DNAJC12 DHDDS CLCN4 DDX3X PDE4D EDC3 HDAC4 TIMM8A CRBN SEC24C NEUROD2 PAH HIVEP2 THRB IPW AFF2 KCNA2 NBN HCN1 SLC2A1 NR2F1 SYNGAP1 MED12 HDAC8 SATB2 SLITRK1 SMARCC2 PAH DNM1 DHCR7 NSDHL PTCHD1 SCN3A STXBP1 DHTKD1 STAG2 SLC1A4 SLC25A13 CRADD PMS2 KRAS SIM1 ACTL6B LHCGR SHROOM4 FTSJ1 HOXA2 UPF3B LINS1 SETBP1 ATP6V1A NIPBL GNE RAI1 HCFC1 DYM HSPG2 MANBA MED12 GNS CACNA1H CXORF56 GALC BSCL2 RREB1 SLC45A1 SEMA3E CPLX1 ADNP TSC2 NTRK2 TSHR ATP1A1 PAH NPAP1 CHD7 CRBN SCN2A ABCD1 BCORL1 SPRED1 TMCO1 SMC3 HAL ATRX GCSH SH3KBP1 CASK MECP2 NKAP IGF1 YY1 PRKAR1A DCPS NRXN1 UBE3A NAGLU RSRC1 MLXIPL TGFBR2 RUSC2 SMPD1 PSMD12 PIGC IGF1 CNKSR2 SPR SARS1 IKBKG YME1L1 GLDC GLUD1 ADAT3 EBP SEMA4A CC2D1A BAZ1B WAC CYFIP2 UBE3A TBC1D24 CCBE1 NDP SIN3A TRIM8 MECP2 C12ORF4 HERC2 ZDHHC9 TLK2 AP3B2 GP1BB ARX UBTF TSHR EZR PIK3CA RIC1 SHROOM4 STXBP1 FAN1 NUS1 ADNP MKRN3-AS1 AASS PTCHD1 ACSL4 NSUN2 CUL4B PANK2 TNIK MBD5 GRIN2A TET3 SLC6A8 GNE BSCL2 PCNT GRIN2D DNM1 ADAT3 LIG4 PANK2 CDK8 GRIK2 GTF2I INPP5E IFNG BMPR1A USP27X APC2 FMN2 ALDH5A1 KIF15 SRPX2 DHCR7 GATAD2B OPHN1 CRKL POGZ GRIN2A FMR1 FOXP1 PTCH1 SH2B1 FMR1 TAF6 TTI2 VPS13A ARV1 SMC1A ALG13 AGTR2 ARG1 PUF60 HERC2 PAK3 GRIA4 TNIK MKRN3 JRK TRAPPC9 TBX1 GABRB3 CNTNAP2 MLH1 DPH1 FLII SETD5 FRMPD4 KRAS PNKP TKT B3GALNT2 NDST1 SNORD116-1 PPP3CA DLG3 GABRB2 PDE4D CNTNAP2 HNMT TSC1 SHANK3 TRIO PAK3 SIK1 METTL23 WASHC4 TBL2 ACY1 DMD PHIP GABRB3 MAP11 SCN1A NBN GABRA5 CAMTA1 PRNP TECR MAPK10 TKT CUL4B ARF1 USP9X RAI1 AMT PLA2G6 SCN1B ARID2 ZNF81 Protein Mutations 0
SNP 0
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: BaselineDescription: 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: BaselineDescription: 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 monthDescription: 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 monthsDescription: 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