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| |  APA: Olanzapine Effective for the Treatment of Bipolar Depression By Bruce Sylvester PHILADELPHIA, PA -- May 27, 2002 -- Olanzapine is superior to placebo in the treatment of bipolar depression, and olanzapine plus fluoxetine demonstrates therapeutic superiority over placebo and olanzapine monotherapy, researchers reported here at the annual meeting of the American Psychiatric Association (APA). "The response was robust and showed no evidence of the drug-induced switch to mania, which has been the limitation in the use of other antidepressants for treating bipolar depressives. There was cycling, but it did not appear to be driven by the use of the antidepressant, as it has in other studies of others," said co-investigator Robert Baker, MD, senior clinical research physician at Eli Lilly Laboratories in Indianapolis, Indiana. In a double-blind, placebo-controlled trial, investigators randomized subjects with bipolar depression and a baseline MADRS rating of 20 to eight weeks of treatment with either olanzapine 5 mg/day to 20 mg/day (270 patients) or placebo (377 patients). The researchers randomized 80 subjects to a combination of olanzapine 6 mg/day or 12 mg/day plus fluoxetine 25 mg/day or 50 mg/day. From week 1 to the end of the study, improvement for both olanzapine-treated groups was superior to the placebo group. Mean MADRS change at eight weeks was significantly greater for the olanzapine group (-12.7) and the olanzapine plus fluoxetine group (-17.1) than for the placebo group (less than 9.4, p<0.001). Improvement among patients taking olanzapine plus fluoxetine was greater than among patients on olanzapine monotherapy (p=0.002). Induction of mania did not differ between cohorts (olanzapine 5.7 percent, placebo 6.7 percent, olanzapine plus fluoxetine 6.4 percent). Adverse events (less than 10 percent) reported from the olanzapine groups were somnolence, weight gain, increased appetite, and dry mouth. Headache and insomnia were common and significant in the placebo group. "Treatment of bipolar depression is a seriously unmet need in psychiatry. There are no FDA-approved treatments. It is viewed in the field as very difficult to treat," Dr. Baker said. "We demonstrated in this study rapid, safe, and effective treatment with olanzapine and with the combination olanzapine-fluoxetine." The study was supported by Eli Lilly and Company.
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