Authors: Tohen, et al.
Title: Olanzapine’s efficacy for relapse prevention in bipolar disorder: A randomized double-blind placebo-controlled 12-month clinical trial.
Reference: World J Psychiatry 2004;5(Suppl 1):51. [Congress abstract]
Purpose: Efficacy trial of olanzapine maintenance in patients following treatment of an acute manic episode with olanzapine.
Study design: Randomized, double-blinded study.
Follow up: 52 weeks.
Patients: 225 olanzapine, 136 placebo.
Treatment: Olanzapine 5–20 mg/day or placebo.
Results: There was a prolonged time to relapse (to a manic, depressive, or mixed episode) in patients receiving olanzapine compared with those receiving placebo (p < 0.001). There were significantly lower rates of relapse into a depressive (35% versus 48%) or manic (16% versus 41%) episode with olanzapine treatment versus placebo. Weight gain in patients receiving olanzapine was 3 kg during the preliminary phase and 1 kg during the double-blinded phase. In comparison, patients receiving placebo had a 2 kg reduction in body weight. Fatigue was reported in 6% of patients receiving olanzapine.