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
Condition: Conduct Disorder; Oppositional Defiant Disorder; Disruptive Behavior 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 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
    

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