Status:
COMPLETED
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
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Conduct Disorder
Oppositional Defiant Disorder
Eligibility:
All Genders
5-12 years
Phase:
PHASE3
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 chi...
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 co...
Eligibility Criteria
Inclusion
- Meets Axis I diagnosis criteria for Conduct Disorder or Oppositional Defiant Disorder or Disruptive Behavior Disorder not otherwise specified (DSM-IV, Diagnostic and Statistical Manual of Mental Diseases, 4th edition) and has a total rating of \>=24 on the Nisonger Child Behavior Rating Form (N-CBRF) Conduct Problem Subscale. (Patients with conduct disorder who also meet DSM-IV criteria for Attention Deficit/Hyperactivity Disorder (AD/HD) are eligible.)
- meets DSM-IV Axis II diagnosis criteria for Mild Mental Retardation, Moderate Mental Retardation or Borderline Intellectual Functioning (diagnoses that represent intelligence quotients \[IQs\] ranging from 35 to 84)
Exclusion
- DSM-IV diagnosis of Pervasive Development Disorder, Schizophrenia, or Other Psychotic Disorders
- head injury as cause of mental impairment
- seizure disorder currently requiring medication
- history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs) 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 :
September 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1999
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00250354
Start Date
September 1 1997
End Date
August 1 1999
Last Update
January 24 2011
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