Nefazodone treatment of major depression in alcohol-dependent patients: A double-blind, placebo-controlled trial

Depression is the most common comorbid psychiatric illness in patients with alcohol dependence. This double-blind study tested the efficacy of nefazod one versus placebo for the treatment of depression in actively drinking alc ohol-dependent patients who were also participating in weekly group treatme nt for alcoholism. Sixty-four subjects with major depression disorder and a lcohol dependence with a history of at least one prior episode of depressio n when not drinking were randomly assigned to receive 12 weeks of either ne fazodone or placebo and participated in a weekly psychoeducational group on alcoholism. Subjects were assessed every 2 weeks for depression, anxiety, side effects, and drinking frequency. Subjects taking nefazodone were signi ficantly more Likely to complete the study (62%) than those taking placebo (34%). Analyses of covariance using drinks per week as a time-dependent cov ariate showed lower Hamilton Rating Scale for Depression scores at week 8 f or endpoint analysis and at weeks 8 and 12 for completers. The endpoint ana lysis demonstrated a significantly greater reponse in the nefazodone group (48%) than in the placebo group (16%). Both groups showed a similarly signi ficant decrease in the average number of alcoholic drinks consumed per day over the course of the study. Although the number of adverse effects was si gnificantly greater for the nefazodone group, there mere no severe adverse events, and nefazodone was well tolerated. Nefazodone is a safe and effecti ve antidepressant to use in a population of alcohol-dependent patients with depression who have a high degree of comorbidity. Nefazodone treatment was superior to placebo in alleviating depression in these patients but did no t add any advantage over the psychoeducational group in terms of drinking o utcomes.