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A Double-blind, Placebo-Controlled Trial

Jack R. Cornelius, MD, MPH; Ihsan M. Salloum, MD, MPH; Joan G. Ehler, MD; Patricia J. Jarrett, MD, PhD; Marie D. Cornelius, PhD; James M. Perel, PhD; Michael E. Thase, MD; Ann Black, MS

Arch Gen Psychiatry. 1997;54(8):700-705.

Abstract
Background
The selective serotonergic medication fluoxetine has demonstrated efficacy in the treatment of major depression and has suggested efficacy in the treatment of alcoholism. However, no completed trials with any selective serotonergic medication have been reported in patients who display both major depression and alcoholism, despite previous observations that both depression and alcoholism are associated with low serotonergic functioning.

Methods
Fifty-one patients diagnosed as having comorbid major depressive disorder and alcohol dependence were randomized to receive fluoxetine (n=25) or placebo (n=26) in a 12-week, double-blind, parallel-group trial. Weekly ratings of depression and alcohol consumption were obtained throughout the 12-week course of the study.

Results
The improvement in depressive symptoms during the medication trial was significantly greater in the fluoxetine group than in the placebo group. Total alcohol consumption during the trial was significantly lower in the fluoxetine group than in the placebo group.

Conclusions
Fluoxetine is effective in reducing the depressive symptoms and the alcohol consumption of patients with comorbid major depressive disorder and alcohol dependence. It is unknown whether these results generalize to the treatment of less depressed and less suicidal alcoholics.

Author Affiliations
From the Department of Psychiatry, Western Psychiatric Institute and Clinic, Pittsburgh, Pa.

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