Sertraline |
Zoloft |
Clinical Trial: Sertraline and Cognitive Therapy in Depressed Alcoholics
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism Depression | Drug: sertraline (Zoloft) Behavior: cognitive behavior therapy | Phase II |
MedlinePlus related topics: Alcoholism; Depression
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Expected Total Enrollment: 100
Study completion: January 2002
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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.
Location Information
South Carolina
Medical University of South Carolina, Charleston, South Carolina, 29425, United States
More Information
Record last reviewed: August 2002
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000458
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Sertraline (Drug Digest)
- Zoloft (Drug Digest)

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