A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and … (NCT00250354) | Clinical Trial Compass
CompletedPhase 3
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
110 participantsStarted 1997-09
Plain-language 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.
Who can participate
Age range5 Years – 12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline.