A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation

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Brief Title

A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation

Official Title

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

Brief Summary

      The purpose of the study is to assess the effectiveness and safety of an oral solution of
      risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder
      in children with mild, moderate, or borderline mental retardation.
    

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 the many different
      treatment approaches to conduct disorder are drug therapy, behavioral treatment,
      psychotherapy, and training for cognitive and social skills. 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, placebo-controlled study to evaluate
      the effectiveness of risperidone (0.02 to 0.06 mg/kg/day) compared with placebo in the
      treatment of children 5 to 12 years of age with mild, moderate, or borderline mental
      retardation, and who display destructive behaviors. The study has two 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) and the Vineland Adaptive Behavior Scale after the first week, patients
      either continue in the double-blind treatment phase or discontinue the study. During the
      treatment phase patients receive an oral solution of risperidone (increasing gradually to a
      maximum dose of 0.06 mg/kg) or placebo to be taken once daily 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 effectiveness is the change in the Conduct
      Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment
      compared with baseline. Additional assessments of effectiveness include: the Aberrant
      Behavior Checklist (ABC), the Behavioral Problems Inventory (BPI), and the Clinical Global
      Impression (CGI). 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 performed both before study initiation and at the
      end of treatment. The study hypothesis is that risperidone is 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 mg/mL or placebo oral solution,
      once daily on Days 1 and 2 at dose of 0.01 mg/kg body weight. Dose is 0.02 mg/kg on Day 3,
      increasing gradually to 0.06 mg/kg (maximum) once daily through 6 weeks. Dosage may be
      increased or decreased at investigator's discretion.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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.

Condition

Conduct Disorder

Intervention

risperidone


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

118


Completion Date

October 1998


Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Conduct Disorder, Oppositional Defiant Disorder, or Disruptive Behavior
             Disorder not otherwise specified, by the Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV), Axis I criteria (patients with conduct disorder who
             also meet DSM-IV criteria for Attention Deficit/Hyperactivity Disorder (AD/HD) are
             eligible)

          -  total rating of >=24 on the Nisonger Child Behavior Rating Form (N-CBRF) Conduct
             Problem Subscale

          -  Diagnosis of Mild Mental Retardation, Moderate Mental Retardation or Borderline
             Intellectual Functioning by DSM-IV Axis II criteria (represents intelligence quotients
             (IQs) ranging from 35 to 84)

          -  Vineland Adaptive Behavior Scale <=84.

        Exclusion Criteria:

          -  Diagnosis of Pervasive Development Disorder or Schizophrenia and/or Other Psychotic
             Disorders by DSM-IV criteria

          -  mental impairment caused by head injury

          -  seizure disorder currently requiring medication

          -  history of tardive dyskinesia (a complication of neuroleptic therapy involving
             involuntary movements of facial muscles) 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.
      

Gender

All

Ages

5 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Janssen Pharmaceutica N.V. Clinical Trial, , 



Administrative Informations


NCT ID

NCT00266552

Organization ID

CR006019



Study Sponsor

Janssen Pharmaceutica N.V., Belgium


Study Sponsor

Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Janssen Pharmaceutica N.V.


Verification Date

January 2011