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:
French National Agency for Research on AIDS and Viral Hepatitis
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
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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:
Drug Information available for:
Interferon
Ribavirin
Paroxetine
Interferon alfa-2a
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
Hepatitis A Vaccines
U.S. FDA Resources
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 |
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
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 Interferon Alfa-2a Interferons Ribavirin Paroxetine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on October 16, 2012
