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Trial NCT00000458

Resource URI: http://static.linkedct.org/resource/trials/NCT00000458
linkedct:brief_title Sertraline and Cognitive Therapy in Depressed Alcoholics
linkedct:condition <http://static.linkedct.org/resource/condition/3728>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date January 2002
linkedct:enrollment 100 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000458
rdfs:label Trial NCT00000458
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/168877>
linkedct:nct_id NCT00000458
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Sertraline and Cognitive Therapy in Depressed Alcoholics
linkedct:org_study_id NIAAAMOA10476
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000458>
linkedct:phase Phase 2
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date August 2002