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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

Primary Purpose

Conduct Disorder, Disruptive Behavior Disorder, Oppositional Defiant Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risperidone
Sponsored by
Janssen Pharmaceutica N.V., Belgium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring conduct disorder, oppositional defiant disorder, disruptive behavior disorder not otherwise specified, ADHD, risperidone, antipsychotropic agents, children

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    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.

    Full Information

    First Posted
    December 16, 2005
    Last Updated
    January 20, 2011
    Sponsor
    Janssen Pharmaceutica N.V., Belgium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00266552
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutica N.V., Belgium

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Conduct Disorder, Disruptive Behavior Disorder, Oppositional Defiant Disorder
    Keywords
    conduct disorder, oppositional defiant disorder, disruptive behavior disorder not otherwise specified, ADHD, risperidone, antipsychotropic agents, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Primary Outcome Measure Information:
    Title
    Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutica N.V. Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutica N.V.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12153826
    Citation
    Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL; Risperidone Disruptive Behavior Study Group. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiatry. 2002 Aug;159(8):1337-46. doi: 10.1176/appi.ajp.159.8.1337.
    Results Reference
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