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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00196664

2004-004102-24

ANRS HC18 PAROPEG

Details and patient eligibility

About

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.

Full description

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

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind