A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression
J Clin Psychiatry 2006;67(5):798-806
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: Olanzapine-fluoxetine combination
has shown efficacy 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 olanzapine-fluoxetine
combination or olanzapine monotherapy in a 6-month
open-label extension study.
Method: 376 patients with DSM-IV bipolar I
disorder, depressed, 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 could choose between olanzapine
monotherapy or olanzapine-fluoxetine combination (6/25, 6/50, or
12/50 mg/day). Three treatment groups were defined
retrospectively according to the medication course
taken from week 1: olanzapine, olanzapine-fluoxetine
combination, or switched. The efficacy measures were
the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Bipolar
Version, and Young Mania Rating Scale. The study
was conducted from July 2000 to May 2002.
Results: Among patients who started in
remission, MADRS total scores did not change significantly
from baseline to endpoint in the olanzapine-fluoxetine
combination (0.8) or olanzapine (0.3) groups, but
increased slightly in the switched (2.3, p = .02) group. For
patients who started in nonremission, MADRS total scores
decreased significantly in all groups (olanzapine-fluoxetine combination: - 5.7, p = .001; olanzapine:
- 11.6, p = .004; switched: - 6.4, p = .015). The majority of
patients who entered the study in nonremission
achieved remission (MADRS total score < = 12) during the
trial (olanzapine - fluoxetine combination: 66.7%,
olanzapine: 64.7%, switched: 62.5%). The overall rate of
depressive relapse was 27.4%, and the overall incidence of
mania emergence was 5.9%.
Conclusions: The present findings suggest that
long-term treatment with olanzapine-fluoxetine
combination may be a useful option for the management of
depressive symptoms and carries a low risk of mania