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      Fluoxetine Appears Monotherapy Safe, Effective For Bipolar Type Major Depressive Episode

      A DGReview of :"Short-term fluoxetine monotherapy for bipolar type II or bipolar NOS major depression - low manic switch rate"
      Bipolar Disorders

      03/16/2004
      By Mary Beth Nierengarten


      Initial therapy with fluoxetine monotherapy appears safe and effective for most patients with bipolar type (BP) II or BP not otherwise specified (NOS), who are diagnosed with a major depressive episode, reports a study from the United States.

      Although selective serotonin re-uptake inhibitors (SSRIs), such as fluoxetine, are used to treat a major depressive episode (MDE) in patients who are not bipolar, the use of these antidepressants in BP II or BP NOS patients with a MDE is controversial based on a perceived risk of antidepressant-induced mania switch episodes.

      Based on previously reported retrospective data that found comparable efficacy and safety with a relatively low hypomanic switch rate between patients with unipolar and bipolar disease treated with monotherapy fluoxetine for MDE, Jay D. Amsterdam and colleagues, University of Pennsylvania School of Medicine, Philadelphia, conducted a prospective analysis of fluoxetine monotherapy for the initial treatment of BP II MDE. A total of 37 patients (34 with BP II MDE and 3 with BP NOS MDE) were treated with fluoxetine for at least 8 weeks (at 20 mg daily for at least the final 4 weeks).

      Efficacy was measured after 1, 2, 4, 6, and 8 weeks of treatment using the17-item Hamilton Depression Rating (HAM-D 17) score. The Young Mania Rating (YMR) scale was used to evaluate treatment-related hypomanic episodes.

      A significant reduction in the mean overall HAM-D 17 scores was found from 21.7 at baseline to 14.8 at the end of 8 weeks (P < .001). A total of 38% of patients responded to treatment, as shown by a reduction of baseline HAM-D 17 score by 50% or greater. Of 23 patients who completed the full 8 weeks of treatment, 48% responded to treatment. Remission, as shown by a final HAM-D 17 score of 9 or less, was reported for 27% of patients.

      Treatment was found safe overall, with most adverse events reported as mild or moderate and causing discontinuation of therapy in only 2 patients. Based on a YMR sore of 8 or greater to identify hypomanic symptoms, there was no difference between hypomanic episodes seen during treatment as seen at baseline. Overall, symptoms suggestive of an hypomaniac episode were seen in 3 patients, which caused treatment discontinuation in only 1 patient.

      The authors conclude that "these observations support findings from prior studies, and suggest that fluoxetine monotherapy may be a safe and effective initial treatment for most patients with BP II or BP NOS MDE."

      Bipolar Disorder 2004 Feb;6:1:75-81. "Short-term fluoxetine monotherapy for bipolar type II or bipolar NOS major depression - low manic switch rate"

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