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

A Randomized, Placebo-Controlled, Dose-Response Trial of Venlafaxine Hydrochloride in the Treatment of Major Depression

Richard L. Rudolph, Louis F. Fabre, John P. Feighner, Karl Rickels, Richard Entsuah, and Albert T. Derivan

Published: March 15, 1998

Article Abstract

Background: We examined the efficacy and safetyof 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 metDSM-III criteria for major depression were included (N=358randomized; 194 completed). Of the total patients completing thetrial, 59%, 56%, 51%, and 51% were in the placebo, 75-mg, 225-mg,and 375-mg groups, respectively. The primary outcome measureswere the Hamilton Rating Scale for Depression (HAM-D21)total, HAM-D21 depression item, Montgomery-AsbergDepression Rating Scale total, and Clinical Global Impressionsscale.

Results: Each dosage of venlafaxine wasassociated with statistically significant improvement as comparedwith placebo, based on the intent-to-treat sample. The two higherdosages were associated with a modestly greater antidepressantresponse than was the 75mg dosage. Nausea, dizziness, somnolence,and anorexia were the most common adverse events attributable tovenlafaxine. Since headache occurred at a similar frequency inboth the drug and placebo groups, we did not consider it to beattributable to venlafaxine use. Withdrawal from the study due toadverse events occurred in 5%, 17%, 24%, and 30% of the patientsin the placebo, 75-mg, 225mg, and 375-mg groups, respectively.

Conclusion: Venlafaxine, at dosages of 75_375mg/day, is an effective and well-tolerated antidepressant. Withincreasing dosage, greater efficacy and possibly more adverseeffects will occur.

Volume: 59

Quick Links:

Continue Reading…

Subscribe to read the entire article


Buy this Article as a PDF