Sertraline and Cognitive Therapy in Depressed Alcoholics - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000458 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Sertraline and Cognitive Therapy in Depressed Alcoholics
Official Title ^ICMJE	Sertraline and Cognitive Therapy in Depressed Alcoholics
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism Depression
Intervention ^ICMJE	Drug: sertraline (Zoloft) Behavioral: cognitive behavior therapy
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	January 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000458
Responsible Party
Study ID Numbers ^ICMJE	NIAAAMOA10476
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP