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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Paroxetine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No