Status:
COMPLETED
Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 prev...
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 hepatiti...
Eligibility Criteria
Inclusion
- \- Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00196664
Start Date
October 1 2005
End Date
February 1 2009
Last Update
May 13 2009
Active Locations (1)
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1
Service d'Hépato-gastroentérologie CHU de Nancy
Vandœuvre-lès-Nancy, France, 54500