A 7-Week, Randomized, Double-Blind Trial of Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression
J Clin Psychiatry 2006;67(7):1025-1033
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: Determine the efficacy and
tolerability of olanzapine/fluoxetine combination (OFC)
for treatment of acute bipolar I depression
compared with lamotrigine.
Method: The 7-week, acute phase of a
randomized, double-blind study compared OFC (6/25,
6/50, 12/25, or 12/50 mg/day; N = 205) with lamotrigine ([LMG] titrated to 200 mg/day; N = 205) in
patients with DSMIV-diagnosed bipolar I disorder,
depressed. The study was conducted from November 2003 to August 2004.
Results: Completion rates were similar
between treatments (OFC, 66.8% vs. LMG, 65.4%;
p = .835). OFC-treated patients had significantly greater
improvement than lamotrigine-treated patients
in change from baseline across the 7-week
treatment period on the Clinical Global
Impressions-Severity of Illness scale (primary outcome) (p = .002,
effect size = 0.26), Montgomery-Asberg Depression
Rating Scale (MADRS) (p = .002, effect size = 0.24), and Young Mania Rating Scale total scores
(p = .001, effect size = 0.24). Response rates did not
significantly differ between groups when defined
as > = 50% reduction in MADRS score (OFC, 68.8%
vs. LMG, 59.7%; p = .073). Time to response was significantly shorter for OFC-treated patients
(median days [95% CI] = OFC, 17 [14 to 22] vs. LMG,
23 [21 to 34]; p = .010). There was a significant
difference in incidence of "suicidal and self-injurious
behavior" adverse events (OFC, 0.5% vs. LMG,
3.4%; p = .037). Somnolence, increased appetite, dry mouth, sedation, weight gain, and tremor
occurred more frequently (p < .05) in OFC-treated
patients than lamotrigine-treated patients. Weight, total
cholesterol, and triglyceride levels were
significantly elevated in OFC-treated patients compared
with lamotrigine-treated patients (all p < = .001).
Conclusions: Patients with acute bipolar I
depression had statistically significantly greater
improvement in depressive and manic symptoms, more treatment-emergent adverse events, greater
weight gain, and some elevated metabolic factors with
OFC than lamotrigine. Treatment differences were
of modest size.