A Randomized, Placebo-Controlled, Dose-Response Trial of Venlafaxine Hydrochloride in the Treatment of Major Depression
J Clin Psychiatry 1998;59(3):116-122
© Copyright 2014 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: We examined the efficacy and safety
of three different dosages of venlafaxine hydrochloride (75, 225,
and 375 mg/day) in a multicenter, randomized, double-blind,
placebo-controlled, four-group study.
Method: Outpatients, 18 to 65 years old, who met
DSM-III criteria for major depression were included (N=358
randomized; 194 completed). Of the total patients completing the
trial, 59%, 56%, 51%, and 51% were in the placebo, 75-mg, 225-mg,
and 375-mg groups, respectively. The primary outcome measures
were the Hamilton Rating Scale for Depression (HAM-D21)
total, HAM-D21 depression item, Montgomery-Asberg
Depression Rating Scale total, and Clinical Global Impressions
Results: Each dosage of venlafaxine was
associated with statistically significant improvement as compared
with placebo, based on the intent-to-treat sample. The two higher
dosages were associated with a modestly greater antidepressant
response than was the 75mg dosage. Nausea, dizziness, somnolence,
and anorexia were the most common adverse events attributable to
venlafaxine. Since headache occurred at a similar frequency in
both the drug and placebo groups, we did not consider it to be
attributable to venlafaxine use. Withdrawal from the study due to
adverse events occurred in 5%, 17%, 24%, and 30% of the patients
in the placebo, 75-mg, 225mg, and 375-mg groups, respectively.
Conclusion: Venlafaxine, at dosages of 75_375
mg/day, is an effective and well-tolerated antidepressant. With
increasing dosage, greater efficacy and possibly more adverse
effects will occur.