Sertraline and Cognitive Therapy in Depressed Alcoholics - Tabular View

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Sertraline and Cognitive Therapy in Depressed Alcoholics

This study has been completed.

Study NCT00000458. Last updated on June 23, 2005. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Sertraline and Cognitive Therapy in Depressed Alcoholics
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism Depression
Intervention ^†	Drug: sertraline (Zoloft) Behavioral: cognitive behavior therapy
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	100
Start Date ^†
Completion Date	January 2002
Eligibility 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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000458
Organization ID	NIAAAMOA10476
Secondary IDs ^††
Study Sponsor ^†	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.