Randomized, Double-Blind Comparison of Venlafaxine and Fluoxetine in Outpatients With Major Depression
J Clin Psychiatry 1998;59:352-357
© Copyright 2014 Physicians Postgraduate Press, Inc.
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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 on the 21item Hamilton Rating
Scale for Depression (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 increased to venlafaxine, 75
mg twice daily, or fluoxetine, 20 mg twice daily, after 3 weeks
for a poor response. The primary efficacy variables were the
final on-therapy scores on the HAM-D, Montgomery-Asberg
Depression Rating Scale (MADRS), and Clinical Global Impressions
Severity of Illness (CGI-S) and Improvement (CGII) scales.
Results: Three hundred eighty-two patients were
randomly assigned to therapy and included in the intent-to-treat
analysis. Both venlafaxine and fluoxetine produced significant
reductions from baseline to day 56 in mean HAM-D, MADRS, and
CGI-S scores, but no significant differences were noted between
groups. Among patients who increased their dose at 3 weeks,
significantly (p < .05) more patients taking venlafaxine than
taking fluoxetine had a CGI-I score of 1 (very much improved) at
the final evaluation. The most frequent adverse events were
nausea, headache, and dizziness with venlafaxine and nausea,
headache, and insomnia with fluoxetine.
Conclusion: These results support the efficacy
and tolerability of venlafaxine in comparison with fluoxetine for
treating outpatients with major depression.