Trial record 1 of 1 for:    NCT00250354
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250354
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : January 24, 2011
Information provided by:
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Conduct Disorder Oppositional Defiant Disorder Disruptive Behavior Disorder Drug: Risperidone oral solution Phase 3

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  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Safety And Efficacy Of Risperidone Versus Placebo In Conduct Disorder In Mild, Moderate And Borderline Mentally Retarded Children Aged 5 To 12 Years
Study Start Date : September 1997
Actual Study Completion Date : August 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250354

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.

Publications of Results: Identifier: NCT00250354     History of Changes
Other Study ID Numbers: CR006007
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
conduct disorder
oppositional deficit disorder
disruptive behavior disorder not otherwise specified
antipsychotropic agents

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Behavioral Symptoms
Neurodevelopmental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents