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Efficacy of Olanzapine and Olanzapine-Fluoxetine Combination in the Treatment of Bipolar I Depression
Mauricio Tohen, MD, DrPH;
Eduard Vieta, MD, PhD;
Joseph Calabrese, MD;
Terence A. Ketter, MD;
Gary Sachs, MD;
Charles Bowden, MD;
Philip B. Mitchell, MD;
Franca Centorrino, MD;
Richard Risser, MS;
Robert W. Baker, MD;
Angela R. Evans, PhD;
Karin Beymer, BS, RPh;
Sanjay Dubé, MD;
Gary D. Tollefson, MD, PhD;
Alan Breier, MD
Arch Gen Psychiatry. 2003;60:1079-1088.
Background Despite the longer duration of the depressive phase in bipolar disorder and the frequent clinical use of antidepressants combined with antipsychotics or mood stabilizers, relatively few controlled studies have examined treatment strategies for bipolar depression.
Objective To examine the use of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression.
Design Double-blind, 8-week, randomized controlled trial.
Setting Eighty-four sites (inpatient and outpatient) in 13 countries.
Patients A total of 833 randomized adults with bipolar I depression with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20.
Intervention Patients were randomly assigned to receive placebo (n = 377); olanzapine, 5 to 20 mg/d (n = 370); or olanzapine-fluoxetine combination, 6 and 25, 6 and 50, or 12 and 50 mg/d (n = 86).
Main Outcome Measure Changes in MADRS total scores using mixed-effects model repeated-measures analyses.
Results During all 8 study weeks, the olanzapine and olanzapine-fluoxetine groups showed statistically significant improvement in depressive symptoms vs the placebo group (P<.001 for all). The olanzapine-fluoxetine group also showed statistically greater improvement than the olanzapine group at weeks 4 through 8. At week 8, MADRS total scores were lower than at baseline by 11.9, 15.0, and 18.5 points in the placebo, olanzapine, and olanzapine-fluoxetine groups, respectively. Remission criteria were met by 24.5% (87/355) of the placebo group, 32.8% (115/351) of the olanzapine group, and 48.8% (40/82) of the olanzapine-fluoxetine group. Treatment-emergent mania (Young Mania Rating Scale score <15 at baseline and  15 subsequently) did not differ among groups (placebo, 6.7% [23/345]; olanzapine, 5.7% [19/335]; and olanzapine-fluoxetine, 6.4% [5/78]). Adverse events for olanzapine-fluoxetine therapy were similar to those for olanzapine therapy but also included higher rates of nausea and diarrhea.
Conclusions Olanzapine is more effective than placebo, and combined olanzapine-fluoxetine is more effective than olanzapine and placebo in the treatment of bipolar I depression without increased risk of developing manic symptoms.
From Lilly Research Laboratories, Indianapolis, Ind (Drs Tohen, Baker, Evans, Dubé, Tollefson, and Breier, Mr Risser, and Ms Beymer); the Department of Psychiatry, Harvard Medical School/McLean Hospital, Belmont, Mass (Drs Tohen and Centorrino); Hospital Clinic, Bipolar Disorders Program, Barcelona, Spain (Dr Vieta); the Department of Psychiatry, Case Western Reserve University, University Hospitals of Cleveland, Cleveland, Ohio (Dr Calabrese); the Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, Calif (Dr Ketter); the Department of Psychiatry, Harvard Medical School/Massachusetts General Hospital, Boston (Dr Sachs); the Department of Psychiatry, The University of Texas Health Sciences Center, San Antonio (Dr Bowden); the School of Psychiatry, University of New South Wales, Sydney, Australia (Dr Mitchell); and Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pa (Dr Dubé).
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