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Sertraline and Cognitive Therapy in Depressed Alcoholics - Article


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Sertraline

Zoloft 




Clinical Trial: 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)

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

Further Study Details: 

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

Study ID Numbers:  NIAAAMOA10476
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



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December 1, 2009



Page Updated: June 1, 2005
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