Long-Term Antidepressant Efficacy and Safety of Olanzapine/Fluoxetine Combination: A 76-Week Open-Label Study
J Clin Psychiatry 2003;64(11):1349-1356
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: The olanzapine/fluoxetine
combination has demonstrated effectiveness in treatment-resistant
depression (TRD). Although this combination is being used by
prescribers, this is the first study to examine long-term use.
Long-term efficacy and safety were therefore investigated in a
group of patients with major depressive disorder (MDD) with and
Method: 560 patients who met DSM-IV diagnostic
criteria for MDD were enrolled in this 76-week, open-label study
(Feb. 2000-July 2002). The Montgomery-Åsberg Depression Rating
Scale (MADRS) total score was the primary efficacy measure.
Safety was assessed via adverse events, vital signs, laboratory
analytes, electrocardiography, and extrapyramidal symptom
Results: MADRS mean total scores decreased 7
points from baseline (31.6 [N = 552]) at 1/2 week of treatment,
11 points at 1 week of treatment, and 18 points at 8 weeks of
treatment. This effect was maintained to endpoint with a mean
decrease of 22 points at 76 weeks. Response and remission rates
for the total sample were high (62% and 56%, respectively), and
the relapse rate was low (15%). Response, remission, and relapse
rates for TRD patients (N = 145) were 53%, 44%, and 25%,
respectively. The most frequently reported adverse events were
somnolence, weight gain, dry mouth, increased appetite, and
headache. At endpoint, there were no clinically meaningful
changes in vital signs, laboratory analytes, or
electrocardiography. There were no significant increases on any
measure of extrapyramidal symptoms.
Conclusions: The olanzapine/fluoxetine
combination showed rapid, robust, and sustained improvement in
depressive symptoms in patients with MDD, including patients with
TRD. The long-term safety profile of the combination was similar
to that of its component monotherapies.