An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00221416|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Aripiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2008|
- Drug: Aripiprazole
- YMRS & CGI [ Time Frame: 6 weeks ]
- OAS CDRS-R [ Time Frame: 6 weeks ]
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): NCT00221416
|Principal Investigator:||Robert A Kowatch, MD||University of Cincinnati|