RANDOMIZED, DOUBLE-BLIND COMPARISON OF VENLAFAXINE AND FLUOXETINE IN OUTPATIENTS WITH MAJOR DEPRESSION

Background: This was an 8-week, multicenter, randomized, double-blind, parallel-group study of the efficacy and tolerability of venlafaxine and fluoxetine. Method: Outpatients with DSM-III-R major depression, a minimum score of 20 an the 21-item Hamilton Rating Scale for Depressi on (HAM-D), and depressive symptoms for at least 1 month were eligible . Patients were randomly assigned to treatment with venlafaxine, 37.5 mg twice daily, or fluoxetine, 20 mg once daily. The dose could be inc reased to venlafaxine, 75 mg twice daily, or fluoxetine, 20 mg twice d airy, after 3 weeks for a poor response. The primary efficacy variable s were the final on-therapy scores on the HAM-D, Montgomery-Asberg Dep ression Rating Scale (MADRS), and Clinical Global Impressions Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Results: Three hun dred eighty-two patients were randomly assigned to therapy and include d in the intent-to-treat analysis. Both venlafaxine and fluoxetine pro duced significant reductions from baseline to day 56 in mean HAM-D, MA DRS, and CGI-S scores, but no significant differences were noted betwe en groups. Among patients who increased their dose at 3 weeks, signifi cantly (p < .05) more patients taking venlafaxine than taking fluoxeti ne had a CGI-I score of 1 (very much improved) at the final evaluation . The most frequent adverse events were nausea, headache, and dizzines s with venlafaxine and nausea, headache, and insomnia with fluoxetine. Conclusion: These results support the efficacy and tolerability of ve nlafaxine in comparison with fluoxetine for treating outpatients with major depression.