A group of 480 patients, aged 19-78 with an HRSD score of at least 17 and who met DSM-III criteria for major depressive disorder were studied. Patients were given placebo for a one-week single-blind run-in period, after which sertraline was administered for eight weeks. This was followed by 44 weeks in which patients received sertraline or placebo on a double-blind, randomised basis. Patients were assessed periodically using the 17-item HRSD and the Clinical Global Impression scales. During the entire double-blind period 24 (13.0%) sertraline patients relapsed compared with 48 (45.7%) placebo patients (P less than 0.001). The protective effect of sertraline was maintained throughout the 44 weeks. The study provides evidence that sertraline prevents relapse of the index episode of depression as well as recurrence of further episodes and has few side-effects.
In a double-blind study we compared fluvoxamine, a new selective serotonin re-uptake inhibitor, with clomipramine. In 36 female inpatients with vital depression, the antidepressant properties of fluvoxamine and clomipramine were studied. Eight patients did not complete the study. During a 4-week treatment period the Hamilton-, Zung-, Clinical Global Impression- and Leyden ratings showed, apart from the last scale in the fluvoxamine group, significant improvement in both groups. In the latter scale, a statistically significant difference was found in favour of clomipramine. Additional anxiolytic-sedative medication was required equally in both groups. CSF data in 10 patients are discussed. Non-specific electrocardiographic (ECG) repolarization disturbances were observed in both groups. Anticholinergic side effects were more prominent with clomipramine than with fluvoxamine; gastrointestinal symptoms and agitation were more prominent with fluvoxamine than with clomipramine. Fluvoxamine did not show particular advantages or disadvantages over clomipramine.
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