DOUBLE-BLIND-STUDY OF THE EFFICACY AND SAFETY OF SERTRALINE VERSUS FLUOXETINE IN MAJOR DEPRESSION

An eight-week double-blind, multicentre study was performed to evaluat e the efficacy and safety of sertraline vs. fluoxetine in the treatmen t of major depression (DSM-III-R). There were 108 out-patients, from n ine Italian centres, entered into the study, of whom 88 were evaluable (48 sertraline, 40 fluoxetine). The final mean daily dose of sertrali ne was 72 mg and for fluoxetine it was 28 mg. Both treatment groups sh owed a statistically significant improvement from baseline at one week , and this was maintained until the end of treatment for all of the fo llowing measures: Hamilton Rating Scales for Depression and Anxiety, t he Montgomery Asberg Depression Rating Scale, Clinical Global Impressi ons Scale, Zung Self-Rating Scale for Anxiety and the Leeds Sleep Eval uation Questionnaire. Although there was a numerical advantage for ser traline on several efficacy measures, there was no statistically signi ficant difference found between the treatment groups. The incidence of adverse events was similar for both treatments; 40.4% for sertraline and 39.3% for fluoxetine. However, adverse events were generally rated by patients as of lower severity in the sertraline group. In addition , for the fluoxetine group, there was a higher incidence of agitation, anxiety and insomnia than for sertraline. Sertraline was considered t o be better tolerated than fluoxetine overall, since only 9.6% of sert raline-treated patients discontinued treatment due to therapy failure whereas in the fluoxetine-treated group this figure was 19.6%. By cont rast, 13.5% of sertraline-treated patients discontinued prematurely be cause of clinical improvement, compared with 10.7% of fluoxetine-treat ed patients.