CompletedPhase 3

Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin

France144 participantsStarted 2005-10

Plain-language summary

Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment Exclusion Criteria: * Allergy to paroxetine * Current antidepressant treatment * Depression diagnosed by the MINI International Neuropsychiatric Interview (MINI, DSM IV) * History of bipolar syndrome * History of psychotic syndrome * Treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation * Renal insufficiency * HIV infection * Breath feeding * Contra-indication to PEG-interferon and or ribavirin

What they're measuring

Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74

Trial details

NCT IDNCT00196664

SponsorFrench National Agency for Research on AIDS and Viral Hepatitis

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

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