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VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients

Primary Purpose

Hepatitis C, Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Citalopram or Placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring Hepatitis C, Depression, Interferon-alpha, Citalopram, ribavirin, antidepressive agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult male or female, age 18 or older Planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic HCV (hepatitis C virus) Exclusion Criteria: Chronic liver disease other than chronic HCV Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy A history of organ transplantation Any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major CNS (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection). Inability to read and write at a level sufficient to complete self-report forms History of significant non-compliance with medical treatments and appointments Patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology Patients with active depression in the previous 3 months and/or those with BDI (Beck Depression Inventory)-II greater than or equal to 15 at the time of study entry. Patients with bipolar disorder or history of bipolar disorder Patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months Active substance abuse, such as alcohol (greater than 80 gm/day), IV (intravenous) drugs, and inhaled drugs. If the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months Patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.

Sites / Locations

  • VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108563
Brief Title
VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients
Official Title
VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to learn more about the effects of interferon and ribavirin combination therapy in people with Hepatitis C. The specific aims are: To assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis C, when depressive symptoms occur, and how severe the depressive symptoms are when they do occur; To identify potential predictors for the development of depressive symptoms; To identify if citalopram, an antidepressant medication, can prevent or lessen the severity of depressive symptoms brought about by interferon therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Depression
Keywords
Hepatitis C, Depression, Interferon-alpha, Citalopram, ribavirin, antidepressive agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Citalopram or Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female, age 18 or older Planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic HCV (hepatitis C virus) Exclusion Criteria: Chronic liver disease other than chronic HCV Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy A history of organ transplantation Any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major CNS (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection). Inability to read and write at a level sufficient to complete self-report forms History of significant non-compliance with medical treatments and appointments Patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology Patients with active depression in the previous 3 months and/or those with BDI (Beck Depression Inventory)-II greater than or equal to 15 at the time of study entry. Patients with bipolar disorder or history of bipolar disorder Patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months Active substance abuse, such as alcohol (greater than 80 gm/day), IV (intravenous) drugs, and inhaled drugs. If the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months Patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.
Facility Information:
Facility Name
VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients

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