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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Interferon-alpha; Interferons; Paroxetine; Ribavirin

Criteria

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