drugset / Trial / NCT00221416
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Phase 3
Completed
30 enrolled
University of Cincinnati
Bristol-Myers Squibb · collabChildren's Hospital Medical Center, Cincinnati · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2005-06
- Primary completion
- 2008-10
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 5 mg | — |
| Subject | Aripiprazole | Other / unclassified | 20 mg | — |