drugset / Trial / NCT00277212
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Phase 4
Completed
1169 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Timeline
- Start
- 2005-12-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 30 mg | Oral |
| Background | Lamotrigine | Small molecule | 100 mg | Oral |
| Background | Lamotrigine | Small molecule | 200 mg | Oral |