A Study of the Safety of Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00236470|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Disruptive Behavior Disorder||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||232 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders - an Open Label Follow-up Trial of CR002020|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||July 2004|
- To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical exam, laboratory tests) conducted throughout the trial.
- To asses long-term efficacy data: changes from baseline to 1 year in Conduct Problem subscale of N-CBRF; VAS-MS changes from baseline through 1 year; CGI-Severity subscale at every visit; C-GAS rated for global functioning at the endpoint.
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): NCT00236470
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|