drugset / Trial / NCT00257972
Study of Aripiprazole in Patients With Bipolar I Disorder
Phase 3
Completed
400 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
Timeline
- Start
- 2004-10
- Primary completion
- 2007-12
- Completion
- 2007-12
Publications
- Background Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.
- Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | — | — |