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Olanzapine-Fluoxetine (Symbyax) Effective for Long-Term Management of Bipolar Depression, Shows Low Risk of Mania Emergence

By Bruce Sylvester

ATLANTA, GA -- May 31, 2005 -- The combination formulation of olanzapine and fluoxetine (Symbyax) appears to be effective for long-term management of depression associated with bipolar disorder, researchers reported here on May 24^th at the American Psychiatric Association (APA) Annual Meeting.

"Notably, the findings also indicate that a matter of great concern to clinicians -- the risk of reemergence of mania -- is low with Symbyx therapy," said Sara A. Corya, MD, Senior Research Physician, Lilly Laboratories, Indianapolis, Indiana, United States, "and that is very good news for treatment of bipolar patients."

The investigators enrolled 376 subjects who were diagnosed with depression associated with bipolar disorder who had finished an acute trial and who had received 1 week of post-trial olanzapine 5 to 20 mg/day. The follow-up study was open-label. At every clinical visit, subjects were allowed to remain on olanzapine or switch to olanzapine-fluoxetine 6/25 mg/day, 12/25 mg/day, or 12/50 mg/day).

The investigators defined three study treatment groups retrospectively, according to medication chosen after week 1: olanzapine, olanzapine-fluoxetine, or switched.

Subjects in all three groups who entered the open-label study in non-remission achieved a significant decrease in total scores on the Montgomery Åsberg Depression Rating Scale (MADRS). A majority of subjects who began the open-label trial in non-remission achieved remission at week 24 (total score </=12, olanzapine-fluoxetine 66.7%, olanzapine 64.7%, Switched 62.5%).

The overall rate of depression relapse was 27.4% and the overall rate of mania emergence was 5.9%, the authors noted.

Symbyax is approved for use in the United States by the Food and Drug Administration for treatment of depression associated with bipolar disorder. Though the exact mechanism of action is unknown, the agent has been shown to affect the three neurotransmitters that are important in the treatment of bipolar depression -- serotonin, dopamine and norepinephrine.

The research was supported by Eli Lilly and Company.


[Presentation title: A 24-Week, Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression. Abstract NR366]

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