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Home > "S" Clinical Trials Conditions > Sertraline and Cognitive Therapy in Depressed Alcoholics  Sertraline and Cognitive Therapy in Depressed Alcoholics
Sertraline and Cognitive Therapy in Depressed Alcoholics
For Condition: Alcoholism,Depression
Status: Completed
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Meets criteria for major depressive episode. - Meets criteria for alcohol abuse or dependence thirty days prior to entering the study. - Has had no more than one previous inpatient medical detoxification. - Able to maintain sobriety for ten days. - Able to read and understand questionnaires and informed consent. - Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting. Exclusion Criteria: - Meets criteria for any other psychoactive substance dependence other than nicotine. - Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study. - Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder. - Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication. - Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study. - Current use of disulfiram (Antabuse) or anti-seizure medications. - Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion. - Hepatocellular disease. - Females who are pregnant, nursing, or not using a reliable form of birth control. - Current charges pending for violent crime (excluding DUI related offenses). - Previous adverse experience with a serotonin reuptake inhibitor. - Current homicidal or suicidal ideation.
Total Enrollment: 100
Location and Contact Information:
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Additional Information:
Study ID Numbers: NIAAAMOA10476;
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000458
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Sertraline and Cognitive Therapy in Depressed Alcoholics
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