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APA: Olanzapine-Fluoxetine Combination Shows Promise for Psychotic Major Depression By Bruce Sylvester PHILADELPHIA, PA -- May 22, 2002 -- Combination therapy of olanzapine and fluoxetine is more effective than olanzapine monotherapy in the treatment of psychotic depression, researchers reported at the annual meeting of the American Psychiatric Association (APA). Investigators, led by Sanjay Dube, MD, conducted two parallel, eight-week double-blind trials, with optional 48-week open-label extensions. The researchers randomized 249 subjects with major depressive disorder (MDD) with psychotic symptoms to one of three treatment groups: 48 to olanzapine-fluoxetine combination (OFC), olanzapine 5 mg/day to 20 mg/day and fluoxetine 20 mg/day to 80 mg/day; 101 to olanzapine 5 mg/day to 20 mg/day; and 100 to placebo. The 24-item Hamilton Depression Rating Scale (HAMD-24) was the primary instrument used to measure efficacy. OFC subjects reached a greater mean total HAMD-24 score reduction (-18.3) than olanzapine (-14.4, p=0.072) and placebo (-11.4, p=0.001) patients. The response rate at end point (50 percent total score decrease) for subjects in the OFC group (56 percent) was greater than for olanzapine subjects (36 percent) or placebo subjects (30 percent). The median time to response for the OFC therapy subjects (12 days) was better than for the placebo subjects (20 days) and equal to that for the olanzapine subjects (12 days). In the open-label extension, 71 percent of OFC responders maintained response. Notably, more OFC partial responders reached full response at end point (25 percent total score decrease at two weeks) when compared with olanzapine responders or placebo responders (64 percent vs. 35 percent vs. 32 percent, respectively). "OFC demonstrated significant HAMD-24 based improvement compared to placebo and tended toward significance versus olanzapine in psychotic major depression. The majority of acute OFC responders maintained response during the 48-week extension. OFC may be a promising treatment augmentation strategy for major depression with psychotic features," the authors concluded. The research was supported by Eli Lilly and conducted at Lilly Research Laboratories in Indianapolis, Indiana. E-mail this page to a friend or colleague! To print, use this version