Fluvoxamine as effective as clomipramine against symptoms of severe depression: results from a multicentre, double‐blind study

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Abstract
Background: Although selective serotonin reuptake inhibitors (SSRIs) are better tolerated than tricyclic antidepressants, their efficacy in severe depression remains to be further elucidated.Method: A double‐blind, multicentre study was conducted in 86 severely depressed inpatients (≥ 25 on the 17‐item Hamilton depression rating scale [HAMD] total score) to compare the efficacy and safety of fluvoxamine with that of clomipramine. Following placebo run‐in, 86 patients were randomised to receive fluvoxamine or clomipramine (100–250 mg/day) for 8 weeks.Results: Fluvoxamine and clomipramine both resulted in marked improvements; there were no statistically significant differences between them on the 17‐item HAMD total score, the clinical global impression severity of illness or global improvement items or the Montgomery–Åsberg depression rating scale, at any visit. At the end of the study, 71% in the fluvoxamine group and 69% in the clomipramine group were responders (≥ 50% decrease in 17‐item HAMD total score). However, fluvoxamine was better tolerated than clomipramine. Clomipramine was associated with a higher incidence of overall and treatment‐related adverse events. In addition, the percentage of patients discontinued prematurely due to adverse events was more than twice as high with clomipramine than with fluvoxamine (24% vs 11%).Conclusion: Fluvoxamine and clomipramine are equally effective in severe depression, but fluvoxamine has a better safety and tolerability profile. Copyright © 2003 John Wiley & Sons, Ltd.