Efficacy and Tolerability of Once-Daily Venlafaxine Extended Release (XR) in Outpatients With Major Depression
J Clin Psychiatry 1997;58(9):393-398
© Copyright 2015 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
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.