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April 1995

Double-blind Parallel Comparison of Three Dosages of Sertraline and Placebo in Outpatients With Obsessive-compulsive Disorder

Author Affiliations

From the Dean Foundation for Health, Research, and Education, Madison, Wis (Dr Greist); Allan Memorial Institute, Montreal, Quebec (Dr Chouinard); Center for Behavioral Medicine, Denver, Colo (Dr DuBoff); Metro Health Medical Center, Jackson, Miss (Dr Halaris); Hennepin County Medical Center, Minneapolis, Minn (Dr Kim); Stanford (Calif) University School of Medicine (Dr Koran); New York State Psychiatric Institute, New York (Dr Liebowitz); Medical University of South Carolina, Charleston (Dr Lydiard); Butler Hospital, Providence, RI (Dr Rasmussen); St Elizabeth's Medical Center, Boston, Mass (Dr White); and Pfizer Inc, New York, NY (Dr Sikes).

Arch Gen Psychiatry. 1995;52(4):289-295. doi:10.1001/archpsyc.1995.03950160039008

Background:  Anecdotal evidence suggests patients with obsessive-compulsive disorder (OCD) are treated with selective serotonin uptake inhibitors at dosages significantly higher than those used with depressed patients. The current study examined the efficacy, safety, and optimal dosing strategy of sertraline in patients with OCD.

Methods:  Three hundred twenty-four nondepressed outpatients with OCD from 11 sites followed identical protocols using a double-blind parallel design. Following 1 week of single-blind placebo, patients were randomly assigned to 12 weeks of treatment with one of three fixed dosages of sertraline (50, 100, or 200 mg/d) or placebo.

Results:  Sertraline patients exhibited significantly greater improvement (P<.05) at end point than placebo patients on all three main efficacy measures in the 50-mg/d and 200-mg/d groups and on one measure in the 100-mg/d group. The placebo response was larger in this population of subjects with OCD than in those previously studied. Adverse experiences were common in the sertraline and placebo groups and appeared to be dose-related in the sertraline-treated patients.

Conclusions:  Results support the safety and efficacy of daily dosages of 50, 100, and 200 mg of sertraline in the short-term treatment of patients with OCD.

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