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

Phase 3

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00196664
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Study Completion: 2009-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-12
• Last Update Posted: 2009-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service d'Hépato-gastroentérologie CHU de Nancy; 🇫🇷 Vandoeuvre, France