Ignite Creation Date:
2024-05-06 @ 9:07 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02906501
Status:
UNKNOWN
Last Update Posted:
2016-09-20
First Post:
2016-09-11
Brief Title:
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction The use of low dose risperidone and other antipsychotic drugs off-label as augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder ADHD and Disruptive Behavioral Disorder DBD has become widely common worldwide usually to help control behavioral difficulties While some argue that agents that block dopaminergic receptors may have a deleterious cognitive effect others stress their moderating effects which possibly improve function in all domains including cognitive functions Only a few studies have examined this topic with inconclusive results
Aim of study To measure the effect of risperidone treatment on various cognitive functions in a population of ADHD diagnosed children and adolescents with normal IQ
Design The study is an observational prospective open label clinical controlled trial The investigators will compare the performance in a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery WebCNP and the IGT in children and adolescents diagnosed with ADHD with and without risperidone
Study population Children and adolescents diagnosed with ADHD 8-17 years old may be eligible for this study We will recruit subjects who their psychiatrist is considering rispieridone treatment those who are already treated with risperidone and subjects with only stimulants treatment All pharmacological treatment is supervised and prescribed to subjects by their personal psychiatrist unrelated to the study
Significance Better knowledge of the specific cognitive effects of this form of therapy will help us guide both clinical decisions and recommended monitoring in daily clinical work
Aim of study To measure the effect of risperidone treatment on various cognitive functions in a population of ADHD diagnosed children and adolescents with normal IQ
Design The study is an observational prospective open label clinical controlled trial The investigators will compare the performance in a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery WebCNP and the IGT in children and adolescents diagnosed with ADHD with and without risperidone
Study population Children and adolescents diagnosed with ADHD 8-17 years old may be eligible for this study We will recruit subjects who their psychiatrist is considering rispieridone treatment those who are already treated with risperidone and subjects with only stimulants treatment All pharmacological treatment is supervised and prescribed to subjects by their personal psychiatrist unrelated to the study
Significance Better knowledge of the specific cognitive effects of this form of therapy will help us guide both clinical decisions and recommended monitoring in daily clinical work
Detailed Description:
Study Purpose To evaluate the effect of atypical antipsychotic augmentation specifically risperidone on specific cognitive domains in adolescents with ADHD and behavioral disturbances
Hypotheses
1 Risperidone will improve performance in tasks assessing attention verbal memory visual memory and working memory in adolescents with ADHD and DBDs
2 Risperidone will impair performance in tasks assessing spatial memory and some executive functions in adolescents with ADHD and DBDs
3 Risperidone but not other atypical antipsychotic will improve performance on the IGT
Study Design
General
This study is an observational prospective open label clinical controlled trial
The planned study will compare performance with and without the effect of risperidone in various cognitive tasks in children and adolescents diagnosed with ADHD
Each subject will perform a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery WebCNP and the Iowa Gambling Test IGT
Experimental Procedure
Each potential subject and his parents will be screened on the phone for the study All enrolled subjects will be instructed to avoid taking any stimulant treatment on the days of assessment sessions On the day of enrolment each subject will be evaluated by a standard basic medical interview and physical and neurological examinations for evidence of current neurological and physical disorders They will also be evaluated by the Development and Well-Being Assessment DAWBA for evidence of any psychiatric disorders Parents will also answer DAWBA questionnaire Subjects who will qualify for the study and their parents will receive a comprehensive explanation on the study and will sign an informed consent form Subjects will then complete The Penn Web-Based Computerized Neurocognitive Battery WebCNP and the Iowa Gambling Test IGT The first session will take approximately 25 hours All subjects will undergo a follow up session approximately a month after the first session The second session will take approximately 2 hours Subjects in Groups II will be instructed to start taking their risperidone after the first session and on the day of the follow up session Subjects on Group III will be instructed to take their risperidone or other atypical antipsychotic treatment on days of the experiment in the night before the session at least 8 hours before the sessions and in the month between them The treatments with Risperidone will be given only according to the decision and guidance of the subjects physician All subjects will be invited to perform the Penn Continuous Performance Test for a third time under the influence of their stimulant treatment Normal IQ will be ascertained using the Ravens Progressive Matrices task which is a part of the WebCNP battery
Hypotheses
1 Risperidone will improve performance in tasks assessing attention verbal memory visual memory and working memory in adolescents with ADHD and DBDs
2 Risperidone will impair performance in tasks assessing spatial memory and some executive functions in adolescents with ADHD and DBDs
3 Risperidone but not other atypical antipsychotic will improve performance on the IGT
Study Design
General
This study is an observational prospective open label clinical controlled trial
The planned study will compare performance with and without the effect of risperidone in various cognitive tasks in children and adolescents diagnosed with ADHD
Each subject will perform a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery WebCNP and the Iowa Gambling Test IGT
Experimental Procedure
Each potential subject and his parents will be screened on the phone for the study All enrolled subjects will be instructed to avoid taking any stimulant treatment on the days of assessment sessions On the day of enrolment each subject will be evaluated by a standard basic medical interview and physical and neurological examinations for evidence of current neurological and physical disorders They will also be evaluated by the Development and Well-Being Assessment DAWBA for evidence of any psychiatric disorders Parents will also answer DAWBA questionnaire Subjects who will qualify for the study and their parents will receive a comprehensive explanation on the study and will sign an informed consent form Subjects will then complete The Penn Web-Based Computerized Neurocognitive Battery WebCNP and the Iowa Gambling Test IGT The first session will take approximately 25 hours All subjects will undergo a follow up session approximately a month after the first session The second session will take approximately 2 hours Subjects in Groups II will be instructed to start taking their risperidone after the first session and on the day of the follow up session Subjects on Group III will be instructed to take their risperidone or other atypical antipsychotic treatment on days of the experiment in the night before the session at least 8 hours before the sessions and in the month between them The treatments with Risperidone will be given only according to the decision and guidance of the subjects physician All subjects will be invited to perform the Penn Continuous Performance Test for a third time under the influence of their stimulant treatment Normal IQ will be ascertained using the Ravens Progressive Matrices task which is a part of the WebCNP battery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None