A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduc… (NCT00266552) | Clinical Trial Compass
CompletedPhase 3
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
118 participants
Plain-language 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.
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:
* 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 Criteria:
* 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.
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