Official Title: “Assessment of the Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin. Multicentric, Double-Blinded, Randomized Study. ANRS HC18 Paropeg”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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. This is a comparative study including two groups of patients randomly allocated : one with paroxetine and the other with the placebo. The rate of depression will be compared between the 2 groups

Intervention(s) in this Clinical Trial

• Drug: Paroxetine

Primary Measures

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

Secondary Measures

• Evolution of depression score (MADRS and BDI scales) to W74,Quality of life (HQL questionnaire), Fatigue, Compliance to PEG-interferon and ribavirin, Virological response at W74 ,Safety

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Overall Clinical Trial Officials and Contacts

Jean Pierre Bronowicki, MD, PhD Principal Investigator Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France  

Overall Contact: Jean-Pierre Bronowicki, MD - PhD 0033383153364 jp.bronowicki@chu-nancy.fr

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196664

Study ID Number: 2004-004102-24

ClinicalTrials.gov Identifier: NCT00196664

Health Authority: France: Afssaps - French Health Products Safety Agency