Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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
Sponsor: Janssen Pharmaceutica N.V., Belgium

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

Original Primary Outcome: Same as current

Current 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.

Original Secondary Outcome: Same as current

Information By: Janssen Pharmaceutica N.V., Belgium

Dates:
Date Received: November 4, 2005
Date Started: September 1997
Date Completion:
Last Updated: January 20, 2011
Last Verified: January 2011