[Evaluation of the efficacy and tolerability of fluoxetine in major depression, Multicenter clinical study].

In an Italian multicenter study, 296 patients (115 males, 181 females) affected with major depression diagnosed according to the criteria of the DSM III-R, were treated for 8 weeks with 20 mg/die fluoxetine (Fluoxeren-Menarini s.r.l.). At the end of the therapy the mean scores on the Hamilton Depression Scale had improved considerably, going down from 27.42 to 10.05. 69.6% of the patients had improved by at least in the 50% in the HAM-D scores (responders). At the CGI the overall improvement was evaluated with a mean score of 2.05 (marked improvement), while the patients assessed themselves at the end of treatment as being from "improved" to "greatly improved". No significant differences in efficacy were found to depend on age, type of depression or response to previous treatment, though younger patients (18-40 years), and those with single or recurring episodes, with atypical depression and good response to other antidepressants, showed a more marked improvement. The tolerability of the drug was found to be good. The laboratory tests, ECG and body weight stayed within normal limits.