Sertraline and Cognitive Therapy in Depressed Alcoholics

Depression Clinical Trial

Official title:

Sertraline and Cognitive Therapy in Depressed Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000458
• Other study ID #: NIAAAMOA10476
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: January 2002

Study information

• Verified date: August 2002
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Depression

Intervention

Drug:
• sertraline (Zoloft)

Behavioral:
• cognitive behavior therapy

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,