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Abilify in Bipolar I Disorder with Major Depressive Episode
NCT00338273Phase 3
Key facts
- Status
- Withdrawn
- Start
- Dec 2006
- Primary completion
- Nov 2007
- Countries
- 2
- Drugs
- aripiprazole
- Conditions
- bipolar I disorder
01
Overview
Phase 3, randomised, double-blind trial in bipolar I disorder comparing Abilify Arm with Placebo Arm (2 arms). Primary endpoint: Montgomery-Asberg Depression Rating Scale at 8 weeks. Planned start Dec 2006; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Abilify Arm
Flexible doses (5-30 mg) of aripiprazole tablets once daily for 8 weeks.
Placebo Arm
Placebo tablets once daily for 8 weeks.
03
Who it enrols
Outpatients with Bipolar I Disorder experiencing a major depressive episode, excluding those with significant suicide risk, unstable medical conditions, or who are pregnant/nursing.
04
Endpoints
Primary
Montgomery-Asberg Depression Rating Scale
Secondary
Clinical Global Impression-Bipolar Version
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