Sertraline and Cognitive Therapy in Depressed Alcoholics

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00000458
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Sertraline and Cognitive Therapy in Depressed Alcoholics

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Alcoholism
Depression
Depressive Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014