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A Double-Blind Comparison of Fluvoxamine and Paroxetine in the Treatment of Depressed Outpatients

J Clin Psychiatry 1997;58:146-152

Background: Fluvoxamine and paroxetine, both serotonin selective reuptake inhibitors (SSRIs), were compared at two centers in a 7week doubleblind study in outpatients with major depression, diagnosed by DSMIIIR criteria.

Method: Sixty patients were randomly assigned to receive dosage titrated upward to between 50_150 mg/day of fluvoxamine (N=30) or 20_50 mg/day of paroxetine (N=30). The mean±SD daily dose administered at the last assessment was 102±44 mg/day for fluvoxamine and 36±13 mg/day for paroxetine. Sixteen (53%) fluvoxamine-treated patients and 10 (33%) paroxetine-treated patients were titrated to the maximum permissible dosage of either drug. Sample size was calculated to provide at least 85% power at 5% level of significance to detect at least a 1.00-point difference in mean severity of adverse events, assuming a standard deviation of 1.0.

Results: Fluvoxamine and paroxetine were similarly effective in ameliorating depression as demonstrated by mean total scores of 10.9±7.3 (p

Conclusion: Observed differences in some side effects, although not statistically significant, indicate that when a patient has difficulty tolerating one SSRI, the clinician may choose to change to a different agent within the same class.