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A double-blind placebo-controlled multicentre study of sertraline in the acute and continuation treatment of major depression

Published online by Cambridge University Press:  16 April 2020

JP Olie ,
KP Gunn  and
E Katz
JP Olie
Affiliation:
Hospital Saint-Anne, Paris, France
KP Gunn*
Affiliation:
Pfizer Central Research, Ramsgate Road, Sandwich, KentCT13 9NJ, UK
E Katz
Affiliation:
Pfizer Central Research, Paris, France
*
*Correspondence and reprints.
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Summary

In a double-blind multicentre study of outpatients with DSM-III-R major depressive disorder, 129 sertraline and 129 placebo patients were evaluated over a 6-week period. Sertraline exhibited a significantly greater (P < 0.001) antidepressant effect compared to placebo as measured by the HAM-D, MADRS, CGI-S and CGI-I. In the subset of patients with severe depression (baseline HAM-D ≥ 25), sertraline was also significantly more effective than placebo (P < 0.05). Side effects were more commonly reported in sertraline (59%) compared to placebo (38%) patients; the most common being nausea, headache and insomnia. A subset of 107 patients (66 sertraline; 41 placebo) who were defined as responders (CGI-I of 1 or 2) after 6 weeks treatment were entered into a 20-week continuation phase. In this responder subset, there was continuing improvement in both groups of patients, but with no significant differences in mean HAM-D or MADRS between the groups. However, a higher number of sertraline patients were associated with a persistent pattern of improvement relative to placebo (P < 0.05). The incidence of side effects was similar in sertraline (52%) and placebo (49%) treated patients in the continuation period.

Keywords

SSRIsertralinemajor depression
Type
Original article
Information
European Psychiatry , Volume 12 , Issue 1 , 1997 , pp. 34 - 41

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