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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

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ClinicalTrials.gov Identifier: NCT00196664
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 13, 2009
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Paroxetine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2005
Actual Study Completion Date : February 2009





Primary Outcome Measures :
  1. Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196664


Locations
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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
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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
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ClinicalTrials.gov Identifier: NCT00196664    
Other Study ID Numbers: 2004-004102-24
ANRS HC18 PAROPEG
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 13, 2009
Last Verified: May 2009
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Chronic Hepatitis C
Paroxetine
Depression
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Depressive Disorder
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mood Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors