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

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00000458 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sertraline and Cognitive Therapy in Depressed Alcoholics
Sertraline and Cognitive Therapy in Depressed Alcoholics

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Alcoholism
  • Depression
  • Drug: sertraline (Zoloft)
  • Behavioral: cognitive behavior therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2002
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000458
NIAAAMOA10476
Not Provided
Not Provided
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not Provided
Not Provided
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP