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
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|ClinicalTrials.gov Identifier: NCT00236444|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit and Disruptive Behavior Disorders||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Risperidone in the Prevention of Relapse: a Randomized, Double-blind, Placebo-controlled Trial in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders.|
|Study Start Date :||December 2001|
|Actual Study Completion Date :||September 2003|
- Time from start of double-blind phase to relapse, using N-CBRF and CGI assessments.
- Comparison of ratings for risperidone and placebo on N-CBRF, CGI, and VAS-MS throughout study. Ratings on C-GAS once during each study phase. Comparison of safety profiles of risperidone and placebo (for example, adverse events, clinical and lab tests).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236444
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|