A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Timeline

Start

2006-12

Primary completion

2008-02

Completion

2008-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Olanzapine vs Placebo; p <0.001; Mixed Models Analysis; NCT00402324 ↗

registry analysis (superiority or other test); Olanzapine vs Placebo; p = 0.022; Mixed Models Analysis; NCT00402324 ↗

Publications

• Houston JP, Gatz JL, Degenhardt EK, Jamal HH. Symptoms predicting remission after divalproex augmentation with olanzapine in partially nonresponsive patients experiencing mixed bipolar I episode: a post-hoc analysis of a randomized controlled study. BMC Res Notes. 2010 Nov 2;3:276. doi: 10.1186/1756-0500-3-276.
• Houston JP, Tohen M, Degenhardt EK, Jamal HH, Liu LL, Ketter TA. Olanzapine-divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Nov;70(11):1540-7. doi: 10.4088/JCP.08m04895yel. Epub 2009 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olanzapine	Small molecule	5 mg	Oral
Subject	Olanzapine	Small molecule	20 mg	Oral
Background	Divalproex Sodium	Small molecule	—	Oral

Indications