Status:
COMPLETED
VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hepatitis C
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108563
Start Date
October 1 2003
End Date
September 1 2006
Last Update
January 21 2009
Active Locations (1)
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1
VA Medical Center
Portland, Oregon, United States, 97239