Treating Alcohol Use In Older Adults With Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

July 3, 2001

Last Updated Date

September 21, 2009

Start Date ^ICMJE

October 1999

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Alcohol use` [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00018824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treating Alcohol Use In Older Adults With Depression

Official Title ^ICMJE

The Treatment of Late Life Major Depression Complication by Alcohol

Brief Summary

The purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

Detailed Description

This study aims to study 80 patients with comorbid alcohol dependence and a depressive syndrome. After appropriate detoxification, patients are started on either naltrexone 50 mg or placebo. After one week, sertraline is added in an open label fashion. It is hypothesized that those patients receiving combination therapy will last 3 months with follow-up tracking lasting 1 year.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Alcoholism
Depression

Intervention ^ICMJE

Drug: NALTREXONE
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Naltrexone
Placebo Comparator: Placebo

Publications *

Oslin DW. Treatment of late-life depression complicated by alcohol dependence. Am J Geriatr Psychiatry. 2005 Jun;13(6):491-500.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age > 55
Current depressive syndrome
Current alcohol dependence
No psychosis
No opioid or cocaine abuse or dependence

Exclusion Criteria:

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00018824

Responsible Party

Oslin, David - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

MHBS-009-98S

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David W. Oslin, MD

University of Pennsylvania

Information Provided By

Department of Veterans Affairs

Verification Date

September 2009

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