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

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196664
First received: September 13, 2005
Last updated: May 12, 2009
Last verified: May 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Estimated Enrollment: 144
Study Start Date: October 2005
Study Completion Date: February 2009
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196664

Locations
France
Service d'Hépato-gastroentérologie CHU de Nancy
Vandoeuvre, France, 54500
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Jean Pierre Bronowicki, MD, PhD Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France
Study Chair: Faiez Zannad, MD C.I.C Nancy France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196664     History of Changes
Other Study ID Numbers: 2004-004102-24, ANRS HC18 PAROPEG
Study First Received: September 13, 2005
Last Updated: May 12, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Chronic Hepatitis C
Paroxetine
Depression

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Depressive Disorder
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mood Disorders
Mental Disorders
Interferon-alpha
Interferons
Ribavirin
Paroxetine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014