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| |  APA: Olanzapine/Fluoxetine (Symbyax) Reduces Depression/Anxiety in Bipolar Patients Without Increased Mania Risk By Bruce Sylvester NEW YORK, N.Y. – May 7, 2004 – A combination of olanzapine and fluoxetine HCl (Symbyax) reduces core mood symptoms as well as depression and anxiety without increasing risk of inducing mania in bipolar patients, researchers said during a presentation of 2 studies here on May 6th at the American Psychiatric Association Annual Meeting. Symbyax is the only treatment approved by the Food and Drug Administration for the treatment of depressive phase bipolar disorder. "We saw 2 important things in these studies," said the lead investigator for both studies, Sara Corya, MD, lead researcher, Lilly Research Labs, Indianapolis, Indiana. "[Montgomery-Asberg Depression Rating Scale] score improvements [showed] mean core mood improvements, not only improvements in somatic symptoms of depression. And Symbyax subjects achieved relatively greater improvement in depression and anxiety symptoms when compared to placebo or olanzapine subjects -- and did not show increased treatment-emergent mania. The last point is a very important one for clinical practice, where the fear of inducing mania with these patients is understandably high." The 2 studies examined data from a base study of 833 subjects diagnosed with bipolar depression who had been enrolled in an 8-week double-blind study; 370 were randomized to olanzapine, 377 to placebo, and 86 to olanzapine/fluoxetine combination. The researchers measured core mood with an index created from the sum of items on the Montgomery-Asberg Depression Rating Scale (MADRS) -- apparent sadness; reported sadness; concentration difficulties; inability to feel; pessimistic thoughts; suicidal thoughts. The investigators used last-observation-carried-forward (LOCF) methodology for their analysis. Results showed that olanzapine/fluoxetine combination (-10.4 single dosing) and olanzapine (-7.5) subjects achieved greater end point decreases in core mood items than placebo (-6.2, P <.001 and P =.02, respectively). And the olanzapine/fluoxetine combination subjects achieved significantly greater improvement in the core mood index than olanzapine (P =.002). The investigators analyzed a subset of 341 patients (olanzapine n = 140; placebo n = 138; olanzapine/fluoxetine = 37) with significant anxiety symptoms (baseline Hamilton Rating Scale for Anxiety [HAM-A] of 18). They evaluated for depression, anxiety, and treatment-emergent mania using MADRS, HAM-A, and the Young Mania Rating Scale (YMRS). They reported that olanzapine/fluoxetine (-18.5) and olanzapine (-13.2) resulted in greater decreases in MADRS than placebo (-8.7, P <.001 and P =.002, respectively). Olanzapine/fluoxetine subjects achieved greater MADRS decreases than olanzapine (P =.04). Olanzapine/fluoxetine (-12.40) and olanzapine (-7.98) subjects achieved greater decreases in HAM-A than placebo (-6.13, P <.001 and P =.044, respectively). Olanzapine/fluoxetine subjects achieved greater HAM-A decreases than olanzapine subjects (P =.01). Treatment-emergent mania (baseline YMRS < 15 and ³15 post-baseline) was similar among all cohorts (combination therapy 6.9%, olanzapine 8.6%, placebo 6.2%, P =.774). The research was supported by Eli Lilly and Company.
[Presentation title: Effect of Olanzapine/Fluoxetine on Core Mood Symptoms in Bipolar Depression. Abstract NR784]
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