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
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|ClinicalTrials.gov Identifier: NCT00250354|
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Conduct Disorder Oppositional Defiant Disorder Disruptive Behavior Disorder||Drug: Risperidone oral solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Safety And Efficacy Of Risperidone Versus Placebo In Conduct Disorder In Mild, Moderate And Borderline Mentally Retarded Children Aged 5 To 12 Years|
|Study Start Date :||September 1997|
|Actual Study Completion Date :||August 1999|
- Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline.
- Changes in Aberrant Behavior Checklist (ABC), Behavioral Problems Inventory (BPI), and Clinical Global Impression (CGI) at end of treatment compared with baseline; incidence of adverse events throughout study.
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): NCT00250354
|Study Director:||Janssen Pharmaceutica N.V. Clinical Trial||Janssen Pharmaceutica N.V.|