Status:
COMPLETED
A Study of the Efficacy and Safety of Risperidone in the Prevention of Relapse in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Attention Deficit and Disruptive Behavior Disorders
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of risperidone as maintenance therapy to prevent symptoms of relapse in children and adolescents with conduct and other disruptive behavi...
Detailed Description
This is a randomized, double-blind study to compare an oral formulation of risperidone with placebo when taken daily over 24 weeks by children and adolescents with conduct and other disruptive behavio...
Eligibility Criteria
Inclusion
- Patients must meet criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV) for Conduct Disorder, Oppositional Defiant Disorder, or Disruptive Behavior Disorder Not Otherwise Specified
- Have a score \>=24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF)
- Have no other significant and untreated or unstable medical illness such as diabetes or hypertension, no serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, or neurological system.
Exclusion
- Patients who meet the DSM-IV criteria for: Pervasive Developmental Disorder
- schizophrenia or other psychotic disorders
- Tourette's Disorder
- Generalized Anxiety Disorder
- Major Depression
- Moderate or severe mental retardation
- Substance Dependence
- Patients with a history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Hypersensitivity or intolerance to risperidone
- Pregnant or nursing females, or those lacking adequate contraception
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00236444
Start Date
December 1 2001
End Date
September 1 2003
Last Update
June 8 2011
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