ASPOFAFF :: Journal - Volume 1 :: Issue 2 :: Vol 1 - Iss 2 - Short Communication - A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression


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ASPOFAFF :: Journal - Volume 1 :: Issue 2 :: Vol 1 - Iss 2 - Short Communication - A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression

Vol 1 - Iss 2 - Short Communication - A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression #29

A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression SA Corya, D Williamson, M Case, D Lin, M Tohen, RC Risser: Lilly Research Laboratories, Indianapolis, IN, USA. Olanzapine-fluoxetine combination (OFC) has been shown to be effective in the acute treatment of depressive episodes in patients with bipolar I disorder. The present analyses examined the efficacy and safety of longer-term treatment with OFC or olanzapine monotherapy in a 6 month open-label extension study. Methods: 376 patients with bipolar depression who completed an acute trial entered the open-label study and received 1 week of olanzapine monotherapy (5-20 mg/day). At all subsequent visits, patients were given the option to stay with olanzapine monotherapy (OLZ), or to change to OFC (6/25, 12/25, or 12/50 mg/day). Three treatment groups were defined retrospectively according to the medication course taken from week 1: OLZ, OFC, or Switched. The efficacy measures were the MADRS, CGI, and YMRS. Results: Mean MADRS scores remained stable for patients who entered the study in remission (mean baseline to endpoint change: OFC -0.7; OLZ 1.4; Switched 3.3), but decreased significantly for those who entered in non-remission (OFC -6.2, p<.001; OLZ –6.5, p=.003; Switched –4.4, p=.016). The majority of patients who entered the study in non-remission achieved remission (MADRS ≤12) during the trial (OFC: 66.7%, OLZ: 64.7%, Switched: 62.5%). The overall rate of depressive relapse was 27.4% and the overall incidence of mania emergence was 5.9%. Conclusion: The present findings suggest that long-term treatment with olanzapine-fluoxetine combination is efficacious in the management of depressive symptoms and carries a low risk of mania emergence.

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