A double-blind comparison of sertraline and fluoxetine in the treatment ofmajor depressive episode in outpatients

Depression is associated with considerable morbidity and mortality. As depr essive disorders carry a high risk of relapse, treatment strategies include the use of a 6-month continuation period after resolution of the acute epi sode. Tolerability is of major importance when determining compliance and o utcome during long-term therapy. Due to the superior tolerability profile o f the selective serotonin reuptake inhibitors (SSRIs) over the older tricyc lic antidepressants (TCAs), the former may be more suitable for extended th erapy. Comparative studies have not shown differences between the SSRIs in terms of efficacy, but side-effect profiles may vary. A multicenter, double -blind, comparative study of sertraline and fluoxetine was carried out in o utpatients fulfilling DSM-III-R criteria for major depressive disorder. Pat ients were randomised to receive sertraline (50-150 mg, n = 118) or fluoxet ine (20-60 mg, n = 120) for 24 weeks. Assessments for depression (HAM-D, HA D, CGI-I, CGI-S), anxiety (Covi), sleep (Leeds Sleep Evaluation scale) and quality of life (SIP) were made at study entry and at weeks 2, 4, 8, 12, 18 and 24. All adverse events were recorded to allow evaluation of tolerabili ty. In total, 88 patients in the sertraline group completed the study compa red with 79 in the fluoxetine group. Side effects were responsible for the premature treatment withdrawal of seven (6%) sertraline patients and 12 (10 %) fluoxetine patients. Two-hundred and thirty-four patients were included in an ITT analysis up to last visit (116 sertraline, 118 fluoxetine). At st udy endpoint, both treatments produced a significant improvement over basel ine on all efficacy variables (P < 0.001). Although the magnitude of global changes in depression, anxiety, and quality of life was larger with sertra line than fluoxetine, none of the between-group differences reached statist ical significance. However, significant differences in favour of sertraline were observed for individual HAM-D items including item 4 (insomnia onset) (P = 0.04), item 9 (agitation) (P = 0.02), and item 13 (general somatic sy mptoms) (P = 0.008). In addition, sertraline was associated with significan tly superior performance on the Leeds Sleep Evaluation scale and on SIP ite ms relating to sleep and rest, emotional behaviour and ambulation. Both ser traline and fluoxetine were well tolerated with no significant differences between treatments. (C) 1999 Elsevier, Paris.