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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Paroxetine

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Paroxetine, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service d'Hépato-gastroentérologie CHU de Nancy

Outcomes

Primary Outcome Measures

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

Secondary Outcome 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

Full Information

NCT ID

NCT00196664

First Posted

September 13, 2005

Last Updated

May 12, 2009

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

1. Study Identification

Unique Protocol Identification Number

NCT00196664

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Chronic Hepatitis C, Paroxetine, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paroxetine

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Pierre Bronowicki, MD, PhD

Organizational Affiliation

Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Faiez Zannad, MD

Organizational Affiliation

C.I.C Nancy France

Official's Role

Study Chair

Facility Information:

Facility Name

Service d'Hépato-gastroentérologie CHU de Nancy

City

Vandoeuvre

ZIP/Postal Code

54500

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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