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
Condition: Conduct Disorder; Disruptive Behavior Disorder; Oppositional Defiant Disorder
MeSH terms: Mental Disorders; Problem Behavior; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: conduct disorder; oppositional defiant disorder; disruptive behavior disorder not otherwise specified; ADHD; risperidone; antipsychotropic agents; children