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

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Brief Title

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

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

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.
    

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 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 oral solution


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

110

Start Date

September 1997

Completion Date

August 1999


Eligibility Criteria

        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.
      

Gender

All

Ages

5 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Janssen Pharmaceutica N.V. Clinical Trial, , 



Administrative Informations


NCT ID

NCT00250354

Organization ID

CR006007



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