drugset / Trial / NCT00665366
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Phase 3
Completed
493 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Timeline
- Start
- 2008-06
- Primary completion
- 2011-10
- Completion
- 2011-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 10 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 15 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 30 mg | — |
| Comparator | Lithium | Unknown | — | — |
| Comparator | Valproate | Small molecule | — | — |