A RANDOMIZED, OPEN-LABEL COMPARISON OF VENLAFAXINE AND FLUOXETINE IN DEPRESSED OUTPATIENTS

In this randomized, open-label, 8-week comparative study, the efficacy and safety of venlafaxine and fluoxetine were assessed in outpatients with major depression. One hundred forty-five patients were assigned to receive venlafaxine 37.5 mg twice daily or fluoxetine 20 mg once da ily. On day 15, if clinically indicated to improve patient response, t he dosage could be increased at the investigator's discretion to venla faxine 75 mg twice daily or fluoxetine 40 mg once daily. One hundred f orty-five patients were evaluated for safety and 110, for efficacy. Th e mean age was 37 years, and 70% of the patients were female. In both treatment groups, mean scores on the Hamilton Depression Rating Scale decreased significantly between baseline (27.8, venlafaxine; 29.2, flu oxetine) and the end of the study (8.7, venlafaxine; 8.2, fluoxetine). Similarly, mean scores on the Montgomery-Asberg Depression Rating Sca le decreased significantly between baseline (31.4, venlafaxine; 31.6, fluoxetine) and the end oi the study (8.3, venlafaxine; 7.6, fluoxetin e). In venlafaxine patients, the most common adverse events were nause a (44.3%), headache (40.0%), insomnia (31.4%), dizziness (30.0%), and dry mouth (22.9%); in fluoxetine patients, they were headache (32.0%), nausea (28.0%), insomnia (24.0%), anxiety (21.3%), sleepiness (20.0%) , and generalized tremor (20.0%). The results of this study indicate t hat venlafaxine is effective and well tolerated for the treatment of m ajor depression at doses of 37.5 or 75 mg twice daily and not signific antly different from fluoxetine 20 or 40 mg once daily.