drugset / Trial / NCT00510146
Olanzapine Treatment of Patients With Bipolar I Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
Timeline
- Start
- 2007-08
- Primary completion
- 2010-03
- Completion
- 2010-07
Publications
- Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Safety and efficacy of olanzapine in the long-term treatment of Japanese patients with bipolar I disorder, depression: an integrated analysis. Psychiatry Clin Neurosci. 2014 Jul;68(7):498-505. doi: 10.1111/pcn.12156. Epub 2014 Mar 4.
- Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Japanese subpopulation analysis of a randomized, double-blind, placebo-controlled study. BMC Psychiatry. 2013 May 14;13:138. doi: 10.1186/1471-244X-13-138.
- Tohen M, McDonnell DP, Case M, Kanba S, Ha K, Fang YR, Katagiri H, Gomez JC. Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry. 2012 Nov;201(5):376-82. doi: 10.1192/bjp.bp.112.108357. Epub 2012 Aug 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Subject | Olanzapine | Small molecule | 15 mg | Oral |
| Subject | Olanzapine | Small molecule | 20 mg | Oral |