Status:
COMPLETED
Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
Lead Sponsor:
Foundation for Liver Research
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology. Prevention of peginterferon-induced psychopathology...
Detailed Description
The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology. Prevention of peginterferon-induced psychopathology...
Eligibility Criteria
Inclusion
- Male and female patients between 18-70 years of age
- Evidence of chronic hepatitis C by detectable serum HCV-DNA
- Hepatitis C genotype 1,2,3 or 4
- Indication for antiviral therapy of hepatitis C according to current clinical guidelines
- Written informed consent
Exclusion
- History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
- Abnormal thyroid stimulating hormone (TSH)
- Presence of contra-indications for antiviral therapy
- Concurrent psychiatric axis I diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria, as the presence of a major depressive episode, bipolar disorder or psychotic disorder.
- Concurrent use of psychotropic drugs such as MAO-inhibitors, St John's wort, Lithium and 5 HT-agonists and antiepileptics.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00133276
Start Date
August 1 2005
End Date
December 1 2009
Last Update
February 19 2010
Active Locations (3)
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1
Erasmus MC University Hospital
Rotterdam, South Holland, Netherlands, 3015GD
2
AMC
Amsterdam, Netherlands, 1100DD
3
Radboud University Hospital
Nijmegen, Netherlands, 6500 HB