Depression Clinical Trial
Official title:
Paroxetine for the Prevention of IFN-Alpha Associated Depression in Patients With Chronic Hepatitis C
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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