This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Research

Efficacy and Tolerability of Once-Daily Venlafaxine Extended Release (XR) in Outpatients With Major Depression

Michael E. Thase, for the Venlafaxine XR 209 Study Group

Published: September 15, 1997

Article Abstract

Background: This was a randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of once-daily venlafaxine extended release (XR) in outpatients with DSM-IV major depression.

Method: Patients were randomly assigned to venlafaxine XR (75_225 mg) once daily or placebo for up to 8 weeks. The primary efficacy variables were the 21-item Hamilton Rating Scale for Depression (HAMD) total score and HAM-D depressed mood item, the Montgomery-Asberg Depression Rating Scale (MADRS) total scores, and the Clinical Global Impressions (CGI) Severity scale. Data were analyzed on a modified intent-to-treat basis using the last-observation- carried-forward method.

Results: Venlafaxine XR (N=91) was significantly more effective than placebo (N=100) beginning at Week 2 on the CGI Severity scale, at Week 3 on the HAM-D depressed mood item, and at Week 4 on the HAM-D and MADRS; this superiority was maintained through Week 8. The most common treatment-emergent adverse events associated with venlafaxine XR were nausea, insomnia, and somnolence. The incidence of nausea was highest during the first week, decreased by 50% during the second week, and was comparable to that of placebo from Week 3 onward.

Conclusion: These results demonstrate that venlafaxine XR is an effective and well-tolerated treatment of major depression.

Volume: 58

Quick Links:

Continue Reading…

Subscribe to read the entire article


Buy this Article as a PDF