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

NCT00266552 | Completed Phase 3

• 1 other identifier: CR006019
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline

Secondary Outcomes (1)

• 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.

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Publications (1)

• 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.

  PMID: 12153826 RESULT

MeSH Terms

Conditions

Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 19, 2005
• Study Completion: October 1, 1998
• Last Updated: January 24, 2011

Record last verified: 2011-01