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A Multicenter Investigation of Fixed-Dose Fluoxetine in the Treatment of Obsessive-compulsive Disorder

Gary D. Tollefson, MD, PhD; Alvin H. Rampey Jr, PhD; Janet H. Potvin, PhD; Michael A. Jenike, MD; A. John Rush, MD; Roberto A. Dominguez, MD; Lorrin M. Koran, MD; M. Katherine Shear, MD; Wayne Goodman, MD; Laura A. Genduso, PharmD
Arch Gen Psychiatry. 1994;51(7):559-567. doi:10.1001/archpsyc.1994.03950070051010.
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Objectives:  To determine the effectiveness of fluoxetine hydrochloride at fixed doses of 20 mg/d, 40 mg/d, and 60 mg/d in patients with obsessive-compulsive disorder (OCD) and to evaluate its safety.

Methods:  Fixed-dose fluoxetine hydrochloride (20 mg/d, 40 mg/d, 60 mg/d) was compared with placebo in two randomized, double-blind, parallel, 13-week trials of identical design in 355 outpatients with OCD aged 15 to 70 years (DSM-III-R criteria; 1 year's duration or longer; depression secondary if present).

Results:  Fluoxetine (all doses) was significantly (P±001) superior to placebo on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score (mean baseline-to-end—point decrease, 4.6,5.5, and 6.5 vs 0.9, respectively, studies pooled) and other efficacy measures (P±01). A trend suggesting greater efficacy at 60 mg/d was observed. Most patients (79.2%) completed the study. Eight adverse events were statistically significantly more frequent with fluoxetine and one, with placebo. For some events, incidence tended to increase with increasing dosage; however, few patients discontinued treatment for any single event.

Conclusion:  Fluoxetine was associated with a statistically significant reduction in OCD severity, including time engaged in obsessional and/or compulsive behaviors. Adverse events infrequently led to study discontinuation.

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