Sertraline for the prevention of relapse in detoxicated alcohol dependent patients with a comorbid depressive disorder: a randomized controlled trial.
OBJECTIVE
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 Asberg 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 >or=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.
Gual
A
A
Unitat de Alcohologia de la Generalitat de Catalunya, Villaroel, Barcelona and Pfizer SA, Parque Empresarial La Moraleja, Madrid, Spain. tgual@clinic.ub.es
Balcells
M
M
Torres
M
M
Madrigal
M
M
Diez
T
T
Serrano
L
L
D000328:Adult; D000368:Aged; D000428:Alcohol Drinking / Q000453:epidemiology; D019973:Alcohol-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003866:Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*; D013030:Spain / Q000453:epidemiology; D013695:Temperance; D016896:Treatment Outcome
D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline