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Two-year placebo-controlled maintenance study to assess recurrence prevention with venlafaxine XR in patients with recurrent unipolar major depression

Published online by Cambridge University Press:  16 April 2020

M. Keller ,
B. Yan ,
J. Musgnung ,
D. Dunner ,
J. Ferguson ,
E. Friedman ,
A. Gelenberg ,
R. Hirschfeld ,
J. Kocsis  and
S. Kornstein
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M. Keller
Affiliation:
Department of Biological Medical Psychiatry and Human Behavior, Brown University, Providence, RI, USA
B. Yan
Affiliation:
Wyeth Pharmaceuticals, Collegeville, PA, USA
J. Musgnung
Affiliation:
Wyeth Pharmaceuticals, Collegeville, PA, USA
D. Dunner
Affiliation:
Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA
J. Ferguson
Affiliation:
Department of Psychiatry, Radiant Research, Salt Lake City, UT, USA
E. Friedman
Affiliation:
Department of Psychiatry, Radiant Research, Salt Lake City, UT, USA Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
A. Gelenberg
Affiliation:
Department of Psychiatry, University of Arizona, Tucson, AZ, USA
R. Hirschfeld
Affiliation:
Department of Psychiatry, University of Texas Medical Branch, Galveston, TX, USA
J. Kocsis
Affiliation:
Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA
S. Kornstein
Affiliation:
Mood Disorders Institute, Virginia Commonwealth University, Richmond, VA, USA
C. Nemeroff
Affiliation:
Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA

Abstract

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Objectives:

This study evaluated the efficacy and safety of venlafaxine extended-release (XR) in preventing recurrence of depression.

Methods:

Outpatients with recurrent unipolar depression (N=1096) were randomly assigned in a 3:1 ratio to 10-week treatment with venlafaxine XR (75 mg/d to 300 mg/d) or fluoxetine (20 mg/d to 60 mg/d). Responders (HAM-D17 ≤12 and ≥50% decrease from baseline) entered a 6-month, double-blind, continuation phase on the same medication. Continuation phase responders enrolled into maintenance treatment consisting of 2 consecutive 12-month phases. At the start of each maintenance phase, venlafaxine XR responders were randomized to double-blind treatment with venlafaxine XR or placebo; fluoxetine responders continued on fluoxetine. Time to recurrence (HAM-D17 >12 and <50% reduction from acute phase baseline at 2 consecutive visits or the last valid visit prior to discontinuation) was evaluated using Kaplan-Meier methods and compared between groups using log-rank tests.

Results:

In the second maintenance phase, the cumulative probabilities of recurrence through 12 months in the venlafaxine XR (n=43) and placebo (n=40) groups were 8.0% (95% CI: 0.0, 16.8) and 44.8% (95% CI: 27.6, 62.0), respectively (P<0.001). The probabilities of recurrence over 24 months for patients assigned to venlafaxine XR (n=129) or placebo (n=129) for the first maintenance phase were 28.5% (95% CI 18.3, 37.8) and 47.3% (95% CI 36.4, 58.2), respectively (P=0.005).

Conclusions:

An additional 12 months of venlafaxine XR maintenance therapy was effective in preventing recurrence in depressed patients who had responded to venlafaxine XR after acute, continuation, and 12 months' initial maintenance therapy.

Type
Poster Session 2: Depressive Disorders
Information
European Psychiatry , Volume 22 , Issue S1: 15th AEP Congress - Abstract book - 15th AEP Congress , March 2007 , pp. S241
Copyright
Copyright © European Psychiatric Association 2007
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