Am J Psychiatry 162:1281-1290, July 2005
© 2005 American Psychiatric Association
Olanzapine Versus Lithium in the Maintenance Treatment of Bipolar Disorder: A 12-Month, Randomized, Double-Blind, Controlled Clinical Trial
Mauricio Tohen, M.D., Dr.P.H.,
Waldemar Greil, M.D.,
Joseph R. Calabrese, M.D.,
Gary S. Sachs, M.D.,
Lakshmi N. Yatham, M.B., F.R.C.P.C.,
Bruno Müller Oerlinghausen, Dr.Med.,
Athanasios Koukopoulos, M.D.,
Giovanni B. Cassano, M.D.,
Heinz Grunze, M.D.,
Rasmus W. Licht, M.D., Ph.D.,
Liliana Dell’Osso, M.D.,
Angela R. Evans, Ph.D.,
Richard Risser, M.Sc.,
Robert W. Baker, M.D.,
Heidi Crane, M.S.,
Martin R. Dossenbach, M.D., and
Charles L. Bowden, M.D.
OBJECTIVE: The authors compared the efficacy of olanzapine and lithium in the prevention of mood episode relapse/recurrence. METHOD: Patients with a diagnosis of bipolar disorder (manic/mixed), a history of two or more manic or mixed episodes within 6 years, and a Young Mania Rating Scale total score  20 entered the study and received open-label cotreatment with olanzapine and lithium for 6–12 weeks. Those meeting symptomatic remission criteria (Young Mania Rating Scale score  12; 21-item Hamilton depression scale score 8) were randomly assigned to 52 weeks of double-blind monotherapy with olanzapine, 5–20 mg/day (N=217), or lithium (target blood level: 0.6–1.2 meq/liter) (N=214). RESULTS: Symptomatic relapse/recurrence (score 15 on either the Young Mania Rating Scale or Hamilton depression scale) occurred in 30.0% of olanzapine-treated and 38.8% of lithium-treated patients. The noninferiority of olanzapine relative to lithium (primary objective) in preventing relapse/recurrence was met, since the lower limit of the 95% confidence interval on the 8.8% risk difference (–0.1% to 17.8%) exceeded the predefined noninferiority margin (–7.3%). Secondary results showed that compared with lithium, olanzapine had significantly lower risks of manic episode and mixed episode relapse/recurrence. Depression relapse/recurrence occurred in 15.7% of olanzapine-treated and 10.7% of lithium-treated patients. Mean weight gain during open-label cotreatment was 2.7 kg; during double-blind monotherapy, weight gain was significantly greater with olanzapine (1.8 kg) than with lithium (–1.4 kg). CONCLUSIONS: These results suggest that olanzapine was significantly more effective than lithium in preventing manic and mixed episode relapse/recurrence in patients acutely stabilized with olanzapine and lithium cotreatment. Both agents were comparable in preventing depression relapse/recurrence.
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