NCT02906501|Unknown
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Sponsor study identifier
observational
45
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 11, 2016
Actual (reported)September 20, 2016
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) scores
1 year
Iowa Gambling Task (IGT) scores
1 year
Male children and adolescents diagnosed with ADHD not treated with risperidone or any other antipsychotic treatment.
Male children and adolescents diagnosed with ADHD intended to start risperidone or any other antipsychotic treatment due to behavioral problems.
Male children and adolescents diagnosed with ADHD treated with risperidone or any other antipsychotic treatment due to behavioral problems.
The Battery (PennCNP) of the Brain Behavior Laboratory at the University of Pennsylvania offers a range of probes of human neuropsychological functioning . It was designed for neuropsychological measurement of major cognitive domains. The WebCNP is administered using clickable icons on desktop or laptop computers, in a fixed order. Administrating the tests in a standard fashion fostering optimal performance without aiding the participant is required. For each domain, accuracy and speed are computed. Full battery completion takes approximately 2 hours. Each test begins with a practice module, to assure understanding of the instructions.
Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. Informed consent will be obtained from potential subjects' parents, and subjects will provide their own assent, according to the local and national IRB committees.
Cognition Research Lab Shalvata Mental Hspital
Hod HaSharon, Israel
First Submitted
September 11, 2016
First Posted
September 20, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
The essential feature of this task is that it mimics real-life situations in the way it factors uncertainty, reward and punishment. The task involves four decks of cards, named A, B, C and D. The goal is to maximize profit on a loan of play money. Subjects are required to make a series of 100 card selections, but are not told ahead of time how many card selections they are going to be allowed to make. Cards can be selected one at a time, from any deck, and subjects are free to switch from any deck to another, at any time and as often as they wish. The decision to select from one deck or another is largely influenced by schedules of reward and punishment. These schedules are pre-programmed and known to the examiner, but not to the subject (Bechara et al., 1994, 1999a).
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 20, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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