An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Aripiprazole is a medication that has been approved by the United States Food and Drug Administration (FDA) for the treatment of Schizophrenia.
A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole. The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder|
- YMRS & CGI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- OAS CDRS-R [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
The primary aim of this study is to assess the effectiveness, safety, and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder. The secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6 gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the occurrence of treatment emergent side effects.