- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000458
Sertraline and Cognitive Therapy in Depressed Alcoholics
June 23, 2005 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
January 1, 2002
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
November 2, 1999
First Posted (ESTIMATE)
November 3, 1999
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 2002
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- NIAAAMOA10476
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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