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A Placebo-Controlled Clinical Trial

Patrick J. McGrath, MD; Edward V. Nunes, MD; Jonathan W. Stewart, MD; Deberah Goldman, PhD; Vito Agosti, MSW; Katja Ocepek-Welikson, MPhil; Frederic M. Quitkin, MD

Arch Gen Psychiatry. 1996;53(3):232-240.

Abstract
Background
Depressive disorders are commonly comorbid with alcoholism, particularly in treatmentseeking samples. If antidepressant treatment were safe and improved the treatment outcome in the subset of actively drinking alcoholics with depression, this would be of clinical importance.

Methods
We conducted a randomized, 12-week placebo-controlled trial of imipramine hydrochloride combined with weekly relapse prevention psychotherapy. The subjects were 69 actively drinking alcoholic outpatients with current depressive disorders. The first onset of depression was either antecedent to the abuse of alcohol or occurred during prolonged periods of sobriety. Depression and drinking outcomes at 12 weeks, as well as their relationship, were measured.

Results
Imipramine treatment was safe and associated with improvement in depression in both adequately treated and intention-to-treat samples. While there was no overall effect on drinking outcome, patients whose mood improved showed decreased alcohol consumption that was more marked in those treated with imipramine.

Conclusions
Imipramine treatment is effective for primary depression among actively drinking alcoholic outpatients, and may improve alcoholic outcome for those whose depression responds to treatment.

Author Affiliations
From the New York State Psychiatric Institute and the College of Physicians and Surgeons, Columbia University, New York, NY.

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