BIPOLAR DISORDER - TOHEN STUDY
Head-to-Head Study
Depakote (divalproex sodium delayed-release tablets) and Olanzapine were studied for the treatment of acute manic or mixed episodes associated with bipolar disorder.11
Primary Endpoint: Mean Change in YMRS† Score at 3 Weeks
STUDY DESIGN:
In a Lilly sponsored, 3-week, randomized, double-blind study of 251 bipolar patients, the primary efficacy measurement evaluated at week 3 was the change in YMRS score from baseline to day 21. Mean baseline YMRS scores were not statistically significantly different between groups.
Adverse events for Depakote and olanzapine were: somnolence (21% v 39%), headache (23% vs 22%), asthenia (14% vs 16%), constipation (12% vs 14%), dyspepsia (11% vs 14%), pain (14% vs 14%), agitation (11% vs 11%), nausea (29% vs 10%), nervousness (17% vs 10%), vomiting (14% vs 8%), diarrhea (14% vs 6%).
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