A large open-label study of venlafaxine in depressed outpatients by community-based physicians

Background: Studies to date suggest that venlafaxine is effective, well tolerated, and safe in a broad spectrum of patients. We examined the clinical utility and tolerability of venlafaxine in patients treated by community-based psychiatrists and family physicians in a naturalistic clinical setting. Method: Nineteen physicians each recruited 10 to 20 physicians to enroll 5 patients each maximum, diagnosed with DSM-IV major depression or dysthymia. The patients were at least moderately ill (Clinical Global Impressions) with a score of at least 32 on the Zung Self-Rating Depression Scale. After baseline clinical and laboratory assessments, each patient received 37.5 mg of venlafaxine b.i.d., with adjustments possible at the 5 visits during the next 8 weeks. Results: Of the 880 patients at baseline, 682 completed the 8-week study. The daily doses of venlafaxine ranged between 18.75 mg and 375 mg, with 80% receiving between 75 and 150 mg/day by 8 weeks. The intent-to-treat analysis revealed that at 8 weeks, 62% (522 of 843) of patients were either much or very much improved. Nausea was the most frequent side effect, followed by somnolence, headache, and dry mouth. Conclusion: Venlafaxine has good clinical utility and tolerability in a community-based sample of a broad spectrum of depressed outpatients.