Fluvoxamine and clomipramine in depressed hospitalised patients: results from a randomised, double-blind study

The efficacy of the selective serotonin reuptake inhibitors (SSRIs) and the tricyclic antidepressants is well established, although data on the efficacy of SSRIs in severe depression is limited. Several studies have demonstrated that fluvoxamine is as effective as clomipramine in the treatment of severe depression. The aim of this four-week study was to compare the efficacy and tolerability of fluvoxamine and clomipramine in hospitalised depressed patients. Patients were eligible for entry into the study if they had an established diagnosis of depression, and an overall score of more than 17 on the first 17-items of the Hamilton Rating Scale for Depression (HAMD). Twenty patients received fluvoxamine 100-300 mg in divided daily doses (mean daily dose 204 mg), and 20 received clomipramine 50-150 mg in divided daily doses (mean daily dose 106 mg) for four weeks. Efficacy was assessed using the HAMD and Clinical Global Impression (CGI) scales, at baseline and weekly intervals thereafter. The investigator's overall rating of efficacy and tolerability was also noted. At the end of the study, both fluvoxamine and clomipramine produced a marked to moderate therapeutic effect. Compared with baseline both fluvoxamine and clomipramine produced similar improvements in the HAMD total, HAMD item and CGI scores. More patients in the clomipramine group experienced anticholinergic side-effects and orthostatic hypotension. Furthermore, a significant difference in favour of fluvoxamine was found with regard to the investigator's overall assessment of undesirable signs and symptoms (p = 0.023; Wilcoxon's test). In conclusion, fluvoxamine is as effective as clomipramine in hospitalised depressed patients, and is better tolerated.