This is a 4-year project that proposes to evaluate with a double-blind, placebo controlled, 14-week clinical trial, whether pharmacologic treatment with sertraline, a potent and selective serotonin reuptake inhibitor, can significantly improve outcome for depressed alcohol dependent patients, when added to a standard hospital-based alcohol recovery treatment program. In addition, their outcome will be compared to that of nondepressed alcohol dependent patients. There will be 100 Ss (20% female), unrestricted by race and ethnic background, half of which will have a DSM-III-R diagnosis of Major Depression, as assessed by the SCID after two weeks of abstinence in inpatient treatment. The remaining 50 nondepressed alcohol dependent Ss will not meet DSM-III-R criteria for any depressive disorder or have a family history of depression, as assessed by the FH-RDC. Within each of the Depressed/Nondepressed groups, eligible Ss will be randomly assigned to either 200 mg/day of sertraline or 4 placebo tablets (maximum dosage will be titrated up in 50 mg increments, over a 2-week inpatient period). During the pharmacotherapy trial, clinical status and adverse effects will be regularly evaluated by a Physician Investigator. Compliance will be monitored with riboflavin marker, sertraline plasma levels and pill counts. A trained rater will also evaluate clinical status at baseline (inpatient) during the 12-week outpatient phase of the pharmacotherapy treatment trial (weekly for 6 weeks, and biweekly for 6 weeks), and at the follow-up visits. After discontinuing medication, Ss will be followed intensively for the first 6 weeks to monitor any development of depressive symptoms, adverse effects or increases in alcohol consumption. Three subsequent follow-up contacts will occur, at 3-month intervals through to 1 year, post-admission to inpatient treatment. Outcome will be determined using multiple measures that will include evaluating number of alcohol-free days, as well as changes in measures of problem severity in areas of medical, employment, psychiatric and social functioning. GGT, urine drug screen and a collateral report will also be obtained monthly for each S during their year-long participation.
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