drugset / Trial / NCT00159783
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
Non-randomizedParallel-groupQuadruple-blindTreatment
Summary
Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-04
- Completion
- 2007-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asenapine | Other / unclassified | 5 mg | — |
| Subject | Asenapine | Other / unclassified | 10 mg | — |
| Comparator | Olanzapine | Small molecule | 5 mg | — |
| Comparator | Olanzapine | Small molecule | 20 mg | — |