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NR376
Tuesday, May 24, 12:00 p.m.-2:00 p.m.
Olanzapine/Fluoxetine Combination Versus Lamotrigine for Bipolar
Depression
Eileen B. Brown, Ph.D., Department of Neuroscience,
Eli Lilly and Company, 3880 Ridge Road, Nederland, CO 80466; Doug
Williamson, M.D., Ahmed Deldar, Ph.D., Paul E. Keck, Jr.,M.D., David
Adams, Ph.D.
Educational Objectives:
At the conclusion of this session, the participant should be able
to discuss the relative merits of olanzapine-fluoxetine combination
and lamotrigine for treatment of bipolar I depression
.
Summary:
Objective: Determine the efficacy of olanzapine-fluoxetine
combination compared with lamotrigine for treatment of bipolar I
depression.
Method: The acute phase of a randomized,
double-blind study compared olanzapine-fluoxetine combination (6/25,
6/50, 12/25, or 12/50 mg/day, N=205) with lamotrigine (200 mg/day;
N=205) in bipolar I depression over seven weeks. Efficacy measures
included Clinical Global Impression Severity (CGI-S) (primary outcome
measure), Montgomery-Asberg Depression Rating Scales (MADRS), and
Young-Mania Rating Scale (YMRS). Analytical techniques included
mixed-models repeated measures analysis on change from baseline
and Fisher’s exact test for categorical comparisons.
Results: Patients treated with OFC had
greater improvement than lamotrigine-treated patients across the
seven-week treatment period on CGI-Severity (p=.002), MADRS total
score (p= .002) and YMRS (p=.001). Time to response (50% decrease
in MADRS) was significantly (p=.010) shorter for OFC-treated patients.
Serious adverse events occurred more frequently in lamotrigine-treated
patients (LMG 5.4%, OFC 1.0%; p=.012). Adverse events occurring
in >=10% patients and more frequently (p<.05) with OFC treatment
were somnolence, increased appetite, dry mouth, sedation, weight
gain and tremor. Weight (p<.001), cholesterol (p<.001) and
triglycerides (p=.001) were significantly elevated with OFC treatment
compared to lamotrigine.
Conclusion: Patients with bipolar depression
had greater improvement in both depressive and manic symptoms on
olanzapine-fluoxetine combination than lamotrigine.
References:
1. Tohen M, Vieta E, Calabrese J, Ketter T, Sachs G, Bowden C, Mitchell
P, Centorrino F, Risser R, Baker R, Evans A, Beymer K, Dube S, Tollefson
G, Brier A: Efficacy of olanzapine and olanzapine-fluoxetine combination
in the treatment of bipolar I depression. Arch Gen Psychiatry 2003;
60:1079-1088.
2. Calabrese J, Bowden C, Sachs G, Ascher J, Monaghan E, Rudd G
for the Lamictal 602 study group: A double-blind, placebo-controlled
study of lamotrigine monotherapy in outpatients
with bipolar I depression. Journal of Clinical Psychiatry 1999;
60:79-88.
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