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Sertraline for Alcohol Dependence and Depression

2014-08-27 03:58:14 | BioPortfolio

Summary

This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.

Description

The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Alcoholism

Intervention

naltrexone (Revia), sertraline (Zoloft), Placebo

Location

Treatment Research Center, University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Completed

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:14-0400

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A randomized, double-blind comparison of aripiprazole/sertraline combination and placebo/sertraline combination in patients with major depressive disorder.

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Medical and Biotech [MESH] Definitions

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A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)

A selective serotonin uptake inhibitor that is used in the treatment of depression.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Component of the NATIONAL INSTITUTES OF HEALTH. It conducts research focused on improving the treatment and prevention of alcoholism and alcohol-related problems to reduce the health, social, and economic consequences of this disease. NIAAA, NIMH, and NIDA were created as coequal institutes within the Alcohol, Drug Abuse and Mental Health Administration in 1974. It was established within the NATIONAL INSTITUTES OF HEALTH in 1992.

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