Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances

NCT02906501 | Unknown

• 1 other identifier: SHA-000-7-16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Risperidone; ADHD; DBD; IGT; CNP; Executive functions

Outcome Measures

Primary Outcomes (1)

• The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) scores

  1 year

Secondary Outcomes (1)

• Iowa Gambling Task (IGT) scores

  1 year

Study Arms (3)

Group I (n=15)

Male children and adolescents diagnosed with ADHD not treated with risperidone or any other antipsychotic treatment.

Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT)

Group II (n=15)

Male children and adolescents diagnosed with ADHD intended to start risperidone or any other antipsychotic treatment due to behavioral problems.

Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT)

Group III (n=15)

Male children and adolescents diagnosed with ADHD treated with risperidone or any other antipsychotic treatment due to behavioral problems.

Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT)

Interventions

The Penn Web-Based Computerized Neurocognitive Battery PROCEDURE

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.

Group I (n=15); Group II (n=15); Group III (n=15)

The Iowa Gambling Test (IGT) PROCEDURE

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).

Group I (n=15); Group II (n=15); Group III (n=15)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Male children and adolescents diagnosed with ADHD Age: 8-17 years.
• Psychiatric comorbidities including: Major Depressive disorder, General Anxiety Disorder, Panic Disorder, Obsessive Compulsive Disorder, Oppositional Defiant Disorder, Conduct Disorder, Disruptive Dysregulation Mood Disorder, Intermittent Explosive Disorder and all phobias.

You may not qualify if:

• Any current serious medical or surgical illness.
• History of a major neurological illnesses (including brain injury).
• Psychiatric comorbidities including: All psychotic disorders, Bipolar Disorder and personality disorders.
• History of alcohol or substance abuse.
• Intellectual disability: Total IQ\< 70

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Cognition Research Lab Shalvata Mental Hspital

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

CHEN DROR, M.D

CONTACT

+9729-7478644; chendr1@clalit.org.il

MAY KOBI, B.S.C

CONTACT

+9729-7478644; mayko@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

IL (1)