Study of Aripiprazole in Patients With Acute Bipolar Mania
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|ClinicalTrials.gov Identifier: NCT00097266|
Recruitment Status : Completed
First Posted : November 22, 2004
Last Update Posted : November 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Placebo Drug: Aripiprazole Drug: Haloperidol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||615 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
|Placebo Comparator: A||
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Other Name: Abilify
|Active Comparator: C||
Capsule, oral, 5-15 mg, once daily, 12 weeks.
- Change in a mania rating scale at endpoint
- Response rate and Clinical Global Impression scale at endpoint
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): NCT00097266
Show 45 Study Locations
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|