Double‐blind multicenter comparison of fluvoxamine versus sertraline in the treatment of depressed outpatients

Fluvoxamine and sertraline, both selective serotonin reuptake inhibitors (SSRIs), were compared in a 5-center, 7-week double-blind study in outpatients with major depression diagnosed by DSM-III-R criteria. Ninety-five patients were titrated from 50 to 150 mg/day of fluvoxamine (n = 49) or 50 to 200 mg/day of sertraline (n = 46). The mean dose administered in Weeks 3-7 was 123.8 mg/day for fluvoxamine, and 137.1 mg/day for sertraline. Forty-seven percent (47%) of fluvoxamine-treated patients and 30% of sertraline-treated patients were titrated to the maximum permissible dose. Fluvoxamine and sertraline were similarly effective in ameliorating depression as demonstrated by a mean reduction from baseline in the Hamilton Rating Scale for Depression (HAMD) total score of 10.61 ± 7.53 and 10.98 ± 6.08, respectively. Adverse events, mostly mild to moderate in severity, were reported for 93.5% of sertraline patients and 85.7% of fluvoxamine patients. The most common events in the sertraline group were insomnia (34.8%), headache (32.6%), diarrhea (23.9%), and ejaculatory difficulty (22.2% of males), and in the fluvoxamine group, nausea (30.6%), headache (26.5%), insomnia (26.5%), and somnolence (24.5%). Significantly more patients reported sexual dysfunction in the sertraline (28%) than in the fluvoxamine (10%) group. An uncharacteristically low dropout rate due to adverse events were observed in the sertraline group (2.2%) compared with the fluvoxamine group (18.4%). The rate of withdrawal due to adverse events in the fluvoxamine group (0-2 patients/center) was comparable to that in the sertraline group (1 patient) for four of the five centers; the fifth center had 4 withdrawals in the fluvoxamine group. The differences in clinical profile of these two SSRIs provided physicians with meaningful choices in antidepressant therapy attuned to individual patient characteristics.