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

Phase 3CompletedNCT00196664

French National Agency for Research on AIDS and Viral Hepatitis144 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

144

Conditions

Chronic Hepatitis C

Interventions

ParoxetineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service d'Hépato-gastroentérologie CHU de Nancy

Vandœuvre-lès-Nancy, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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