A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation

January 20, 2011 updated by: Janssen Pharmaceutica N.V., Belgium

The Safety And Efficacy Of Risperidone Versus Placebo In Conduct Disorder In Mild, Moderate And Borderline Mentally Retarded Children Aged 5 To 12 Years

The purpose of the study is to assess the safety and effectiveness of oral risperidone (an antipsychotic medication) in the treatment of conduct disorder and other disruptive behavior disorders in children ages 5 to 12 with mild, moderate, or borderline mental retardation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conduct and psychiatric disorders are found among a higher proportion of people with mental retardation than among people who are not mentally retarded. Among many different treatment approaches to conduct disorder are drug therapy, behavioral treatment, psychotherapy, cognitive and social learning. Studies have suggested that neuroleptic drugs, such as risperidone, may be beneficial in treating conduct disorder in mental retardation. This is a randomized, double-blind study to evaluate the effectiveness of risperidone compared with placebo in the treatment of children 5 to 12 years of age with mild, moderate, or borderline mental retardation who display destructive behaviors. The study has 2 phases: a run-in phase of 1 week and a treatment phase of 6 weeks. Patients receive placebo to be taken orally once a day during the first week (run-in). On the basis of scores on the Nisonger Child Behavior Rating Form (N-CBRF) after the first week, patients either continue in the double-blind treatment phase or discontinue the study. During the treatment phase patients receive risperidone oral solution once daily at a starting dose of 0.01 mg/kg body weight, increasing gradually at the investigator's discretion up to 0.06 mg/kg (maximum), or placebo for 6 weeks. A parent or caregiver evaluates the child's behavior and symptoms at scheduled office visits during the course of treatment. The primary measure of efficacy is the change from baseline to the end of treatment in the Conduct Problem subscale of the N-CBRF. Other efficacy assessments include the changes in the Aberrant Behavior Checklist (ABC), Behavioral Problems Inventory (BPI), and the Clinical Global Impression (CGI), a rating system used to evaluate the overall and severity of clinical change. Safety assessments include the incidence of adverse events throughout the study; weekly measurement of vital signs (pulse, temperature, blood pressure) and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale (ESRS); and clinical laboratory tests (hematology, biochemistry, urinalysis) before study initiation and at end of treatment. The study hypothesis is that risperidone will be well tolerated and effective for the treatment of conduct disorder in children aged 5 to 12 years with mild, moderate, or borderline mental retardation. Risperidone oral solution 1.0 mg/mL once daily. Days 1 and 2 at a dose of 0.01 mg/kg body weight, Day 3 at a dose of 0.02 mg/kg, and increasing gradually up to 0.06 mg/kg (maximum) daily through 6 weeks. Dose may be increased or decreased at investigator's discretion

Study Type

Interventional

Enrollment (Actual)

110

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 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets Axis I diagnosis criteria for Conduct Disorder or Oppositional Defiant Disorder or Disruptive Behavior Disorder not otherwise specified (DSM-IV, Diagnostic and Statistical Manual of Mental Diseases, 4th edition) and has a total rating of >=24 on the Nisonger Child Behavior Rating Form (N-CBRF) Conduct Problem Subscale. (Patients with conduct disorder who also meet DSM-IV criteria for Attention Deficit/Hyperactivity Disorder (AD/HD) are eligible.)
  • meets DSM-IV Axis II diagnosis criteria for Mild Mental Retardation, Moderate Mental Retardation or Borderline Intellectual Functioning (diagnoses that represent intelligence quotients [IQs] ranging from 35 to 84)

Exclusion Criteria:

  • DSM-IV diagnosis of Pervasive Development Disorder, Schizophrenia, or Other Psychotic Disorders
  • head injury as cause of mental impairment
  • seizure disorder currently requiring medication
  • history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
  • known hypersensitivity, intolerance, or unresponsiveness to risperidone.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline.

Secondary Outcome Measures

Outcome Measure
Changes in Aberrant Behavior Checklist (ABC), Behavioral Problems Inventory (BPI), and Clinical Global Impression (CGI) at end of treatment compared with baseline; incidence of adverse events throughout study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica N.V., Belgium

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.

General Publications

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

September 1, 1997

Study Completion (ACTUAL)

August 1, 1999

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (ESTIMATE)

November 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006007

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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