Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Phase 3 Completed 224 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

Timeline

Start: 2005-07
Primary completion: 2009-01
Completion: 2009-01

Outcome

Met primary endpoint

paper YMRS total score significantly decreased in the olanzapine group compared with the placebo group (-5.62 [95% CI: -8.87, -2.37], p<0.001) after 3 weeks. PMID 22134043 ↗

Publications

Katagiri H, Takita Y, Tohen M, Higuchi T, Kanba S, Takahashi M. Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. J Affect Disord. 2012 Feb;136(3):476-84. doi: 10.1016/j.jad.2011.10.045. Epub 2011 Nov 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Haloperidol	Other / unclassified	2.5 mg	Oral
Comparator	Haloperidol	Other / unclassified	10 mg	Oral
Subject	Olanzapine	Small molecule	5 mg	Oral
Subject	Olanzapine	Small molecule	20 mg	Oral