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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 - Article


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Paroxetine

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

This study is not yet open for patient recruitment.
Verified by French National Agency for Research on AIDS and Viral Hepatitis September 2005

Sponsors and Collaborators: French National Agency for Research on AIDS and Viral Hepatitis
GlaxoSmithKline
Information provided by: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00196664

Purpose

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.
Condition Intervention Phase
Chronic Hepatitis C
  Drug: Paroxetine
 Phase III

MedlinePlus related topics:  Hepatitis;   Hepatitis C

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
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
Expected Total Enrollment:  144

Study start: September 2005

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00196664

Jean-Pierre Bronowicki, MD - PhD      0033383153364    jp.bronowicki@chu-nancy.fr

France
      Service d’Hépato-gastroentérologie CHU de Nancy, Vandoeuvre,  54500,  France
Jean Pierre Bronowicki, MD, PhD  00 33 3 83 15 33 64    jpbronowicki@chu-nancy.fr 
Jean Pierre Bronowicki, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Jean Pierre Bronowicki, MD, PhD,  Principal Investigator,  Service d’Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France   
Faiez Zannad, MD,  Study Chair,  C.I.C Nancy France   

More Information

Study ID Numbers:  2004-004102-24; ANRS HC18 PAROPEG
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00196664
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-20


Source: ClinicalTrials.gov
Cache Date: September 21, 2005

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Page Updated: June 1, 2005
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