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.