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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00018824
Other study ID # MHBS-009-98S
Secondary ID
Status Completed
Phase Phase 4
First received July 3, 2001
Last updated September 21, 2009
Start date October 1999
Est. completion date January 2005

Study information

Verified date September 2009
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Age > 55

- Current depressive syndrome

- Current alcohol dependence

- No psychosis

- No opioid or cocaine abuse or dependence

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
NALTREXONE

Placebo


Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol use` 12 weeks No
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