Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218556
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Rhode Island Hospital
Information provided by (Responsible Party):
, Rhode Island Hospital

Brief Summary:
The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Hepatitis C Behavioral: Cognitive behavioral treatment for depression Not Applicable

Detailed Description:

The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC).

We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Depression in MMT Patients on Interferon
Study Start Date : January 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Depression prevention
Cognitive behavioral treatment for depression.
Behavioral: Cognitive behavioral treatment for depression
Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
No Intervention: Control
Treatment as usual.

Primary Outcome Measures :
  1. depression-related antiviral treatment failure [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Currently undergoing HCV treatment at RIH
  • Enrolled in MMT for at least 6 months

Exclusion Criteria:

  • Current major depressive episode
  • Current suicidality
  • Currently taking antidepressant medication
  • Received HCV treatment in past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218556

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Rhode Island Hospital
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital

Responsible Party: , Associate Professor (Research), Rhode Island Hospital Identifier: NCT00218556     History of Changes
Other Study ID Numbers: NIDA-16797-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2015

Keywords provided by , Rhode Island Hospital:
Hepatitis C, Depressive Symptoms

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mood Disorders
Mental Disorders