drugset / Trial / NCT00095511
Aripiprazole in Patients With Acute Mania
Phase 3
Completed
615 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
Timeline
- Start
- 2004-06
- Primary completion
- 2007-05
- Completion
- 2007-05
Publications
- Background Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.
- McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 15 mg | — |
| Subject | Aripiprazole | Other / unclassified | 30 mg | — |