Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: Paroxetine
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: French National Agency for Research on AIDS and Viral Hepatitis Other
Overall Clinical Trial Officials and Contacts
Jean Pierre Bronowicki, MD, PhD Principal Investigator Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00196664
