Alcohol & Alcoholism Vol. 38, No. 6, pp. 619-625, 2003
© 2003 Medical Council on Alcohol
SERTRALINE FOR THE PREVENTION OF RELAPSE IN DETOXICATED ALCOHOL DEPENDENT PATIENTS WITH A COMORBID DEPRESSIVE DISORDER: A RANDOMIZED CONTROLLED TRIAL
1 Unitat de Alcohologia de la Generalitat de Catalunya, Villaroel, Barcelona and 2 Pfizer SA, Parque Empresarial La Moraleja, Madrid, Spain
(Received 20 February 2003; accepted 12 August 2003)
* Author to whom correspondence should be addressed at: Unitat de Alcohologia de la Generalitat de Catalunya,Villaroel, 170–08036, Barcelona, Spain. Tel.: +39 93 227 5548; Fax: +39 93 227 5454; E-mail: tgual{at}clinic.ub.es
Aims: We performed a double-blind, placebo-controlled randomized trial of sertraline in recently detoxified alcohol-dependent patients with current depressive symptoms. The objectives of the study were to evaluate the efficacy of sertraline at achieving stable abstinence, at ameliorating depressive symptoms and at improving quality of life in these patients. Methods: The study included 83 patients, who received either sertraline (50–150 mg/day) or placebo for 24 weeks. The primary outcome criteria were the rate of relapse into alcohol consumption and the rate of response on the Montgomery and Åsberg Depression Rating Scale (MADRS). Results: At the end of the treatment period, relapse rates were 23.1% in the placebo group and 31.8% in the sertraline group. Responder rates for depression were 38.5% for the placebo group and 44.2% for the sertraline group. There was no significant difference between treatment groups with either variable. However, when patients were stratified into severe (MADRS score 
26) and moderate (MADRS score <26) depression at inclusion, a significant treatment benefit with sertraline was observed in the former group. Quality of life, determined by the SF-36, improved in both groups, with more benefit observed for the sertraline group on mental health items. Sertraline was well tolerated, and the incidence of adverse events was similar in the two treatment groups. Conclusions: The explanation for the overall good outcome in both treatment groups and for the inability to demonstrate a clear treatment effect may reside in the clinical features of the patients included.
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