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Sertraline and Cognitive Therapy in Depressed Alcoholics

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00000458
  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 Intervention Phase
Alcoholism
Depression
Drug: sertraline (Zoloft)
Behavioral: cognitive behavior therapy
Phase II

MedlinePlus related topics:   Alcoholism    Depression   

Drug Information available for:   Sertraline hydrochloride    Sertraline   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:   Sertraline and Cognitive Therapy in Depressed Alcoholics

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:   100
Estimated Study Completion Date:   January 2002

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000458

Locations
United States, South Carolina
Medical University of South Carolina    
      Charleston, South Carolina, United States, 29425

Sponsors and Collaborators
  More Information


Study ID Numbers:   NIAAAMOA10476
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000458
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Depression
Mental Disorders
Alcoholism
Substance-Related Disorders
Sertraline
Disorders of Environmental Origin
Alcohol-Related Disorders
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on October 31, 2008




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