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Treating Alcohol Use In Older Adults With Depression
This study has been completed.
First Received: July 3, 2001   Last Updated: September 21, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018824
  Purpose

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


Condition Intervention Phase
Alcoholism
Depression
Drug: NALTREXONE
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: The Treatment of Late Life Major Depression Complication by Alcohol

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Alcohol use` [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: October 1999
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Naltrexone
Drug: NALTREXONE
2: Placebo Comparator
Placebo
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018824

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: David W. Oslin, MD University of Pennsylvania
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Oslin, David - Principal Investigator )
Study ID Numbers: MHBS-009-98S
Study First Received: July 3, 2001
Last Updated: September 21, 2009
ClinicalTrials.gov Identifier: NCT00018824     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Sensory System Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Naltrexone
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009