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 2015 Physicians Postgraduate Press, Inc.
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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.