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A Double-Blind Comparison of Fluvoxamine and Paroxetine in the Treatment of Depressed Outpatients
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<.00) and 11.5±7.4 (p<.00), respectively, in the Hamilton Rating Scale for Depression (HAM-D). Adverse events were mostly mild to moderate in severity. The most common events were headache (N=17, 57%), nausea (N=14, 47%), sweating (N=10, 33%), somnolence (N=9, 30%), diarrhea (N=9, 30%), dry mouth (N=8, 27%), dizziness (N=8, 27%), and, among males, impotence (N=3, 21%) and ejaculatory abnormality (N=3, 21%) in the paroxetine group, and headache (N=12, 40%), somnolence (N=12, 40%), nausea (N=11, 37%), dry mouth (N=11, 37%), insomnia (N=9, 30%), asthenia (N=7, 23%), and dyspepsia (N=7, 23%) in the fluvoxamine group. The only statistically significant difference between treatment groups was for sweating (33% paroxetine vs. 10% fluvoxamine, p=.028).
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.