Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
A.OVERVIEW
This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the
development of depression and neurotoxicity in patients receiving either 3 million units of
subcutaneous IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG
(polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin
(800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24
to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged
allowing for once a week dosing. Studies indicate that the side effect profile of the two
forms of IFN-alpha treatment are very similar. CHC patients will be screened for study
eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be
enrolled across three sites (30 at Emory site and a combination of 30 from the University of
Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical
Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients
who meet inclusion and exclusion criteria will be stratified on the basis of a history of
major depression and then randomly assigned to paroxetine or placebo in double blind fashion.