- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236444
A Study of the Efficacy and Safety of Risperidone in the Prevention of Relapse in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Risperidone in the Prevention of Relapse: a Randomized, Double-blind, Placebo-controlled Trial in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders.
The purpose of this study is to assess the efficacy and safety of risperidone as maintenance therapy to prevent symptoms of relapse in children and adolescents with conduct and other disruptive behavior disorders, who initially responded well to treatment.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a randomized, double-blind study to compare an oral formulation of risperidone with placebo when taken daily over 24 weeks by children and adolescents with conduct and other disruptive behavior disorders.
Patients who do not respond to treatment after an initial 6-week open-label phase, or do not show continued response after 12 weeks, must leave the trial and will not enter into the 24-week double-blind phase.
The principal measure of efficacy is the time to symptom relapse.
Relapse is assessed by changes in following measures: the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF), a measure of symptoms of conduct and other disruptive behavior disorders and Clinical Global Impression-Severity of Illness (CGI-Severity), and a measure of overall severity of illness.
Efficacy assessment also includes Clinical Global Impression-Change (CGI-C), an assessment of improvement, and Visual Analogue Scale for the most troublesome symptom (VAS-MS), which is a scale ranging from not troublesome to extremely troublesome, and Children's Global Assessment Scale (C-GAS), which is an assessment of overall functioning.
Safety evaluations include incidence of adverse events, physical examinations, laboratory tests (biochemistry, hematology, and urinalysis), and electrocardiograms (ECGs).
The study hypothesis is that daily treatment with an oral formulation of risperidone, compared with placebo, will result in a clinically significant difference in time to relapse, and is well tolerated by children and adolescents with conduct and other disruptive behavior disorders.
Oral risperidone solution (1milligram[mg]/milliliter [ml]), daily for 36 weeks.
Patients weighing at least 50 kilograms start at 0.5 ml/day and may increase up to.1.5
ml/day.
Patients under 50kg start at 0.25ml/day and may increase to 0.75ml/day (maximum).
Study Type
Interventional
Enrollment (Actual)
375
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must meet criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV) for Conduct Disorder, Oppositional Defiant Disorder, or Disruptive Behavior Disorder Not Otherwise Specified
- Have a score >=24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF)
- Have no other significant and untreated or unstable medical illness such as diabetes or hypertension, no serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, or neurological system.
Exclusion Criteria:
- Patients who meet the DSM-IV criteria for: Pervasive Developmental Disorder
- schizophrenia or other psychotic disorders
- Tourette's Disorder
- Generalized Anxiety Disorder
- Major Depression
- Moderate or severe mental retardation
- Substance Dependence
- Patients with a history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Hypersensitivity or intolerance to risperidone
- Pregnant or nursing females, or those lacking adequate contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time from start of double-blind phase to relapse, using N-CBRF and CGI assessments.
|
Secondary Outcome Measures
Outcome Measure |
---|
Comparison of ratings for risperidone and placebo on N-CBRF, CGI, and VAS-MS throughout study. Ratings on C-GAS once during each study phase. Comparison of safety profiles of risperidone and placebo (for example, adverse events, clinical and lab tests).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2001
Study Completion (Actual)
September 1, 2003
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Neurodevelopmental Disorders
- Disease
- Problem Behavior
- Mental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR002020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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