Olanzapine Versus Lithium in the Maintenance Treatment of Bipolar Disorder: A 12-Month, Randomized, Double-Blind, Controlled Clinical Trial

• DOI: 10.1176/appi.ajp.162.7.1281
• Publication Date: 2005-07-01T02:45:41Z
• Authors: Mauricio Tohen; Waldemar Greil; Joseph R. Calabrese; Gary S. Sachs; Lakshmi N. Yatham; Bruno Müller Oerl...; Athanasios Koukop...; Giovanni B. Cassano; Heinz Grunze; Rasmus W. Licht; Liliana Dell’Osso; Angela R. Evans; Richard Risser; Robert W. Baker; Heidi Crane; Martin R. Dossenbach; Charles L. Bowden
• Keywords: Mood stabilizer

OBJECTIVE: The authors compared the efficacy of olanzapine and lithium in prevention mood episode relapse/recurrence. METHOD: Patients with a diagnosis bipolar disorder (manic/mixed), history two or more manic mixed episodes within 6 years, Young Mania Rating Scale total score ≥20 entered study received open-label cotreatment for 6–12 weeks. Those meeting symptomatic remission criteria (Young ≤12; 21-item Hamilton depression scale ≤8) were randomly assigned to 52 weeks double-blind monotherapy olanzapine, 5–20 mg/day (N=217), (target blood level: 0.6–1.2 meq/liter) (N=214). RESULTS: Symptomatic relapse/recurrence (score ≥15 on either scale) occurred 30.0% olanzapine-treated 38.8% lithium-treated patients. noninferiority relative (primary objective) preventing was met, since lower limit 95% confidence interval 8.8% risk difference (–0.1% 17.8%) exceeded predefined margin (–7.3%). Secondary results showed that lithium, had significantly risks Depression 15.7% 10.7% Mean weight gain during 2.7 kg; monotherapy, greater (1.8 kg) than (–1.4 kg). CONCLUSIONS: These suggest effective patients acutely stabilized cotreatment. Both agents comparable