Status:
COMPLETED
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
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Conduct Disorder
Disruptive Behavior Disorder
Eligibility:
All Genders
5-12 years
Phase:
PHASE3
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 1998
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00266552
End Date
October 1 1998
Last Update
January 24 2011
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