Sertraline and Cognitive Therapy in Depressed Alcoholics | NCT00000458

Studies
Sertraline and Cognitive Therapy in Depressed Alcoholics

NCT00000458

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

100

Phase

Phase 2

Conditions

Alcoholism
Depression

Interventions

sertraline (Zoloft)
cognitive behavior therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Jan 2002

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Nov 2, 1999

First Posted Date

Nov 3, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
sertraline (Zoloft)	Drug
cognitive behavior therapy	Behavioral

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D020280	Sertraline
D015928	Cognitive Behavioral Therapy

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes

ID	Term
D000437	Alcoholism
D003863	Depression