Status:
COMPLETED
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary end points * incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype) * effect of...
Eligibility Criteria
Inclusion
- Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA \>1000 IU/ml, naive to antiviral treatment
- age \>18 years
Exclusion
- Antidepressive treatment within the last 3 years
- Psychiatric diseases including major depressive disorders in past medical history
- Active substance abuse during the last 12 months
- Pregnancy, lactation, wish to become pregnant
- Hepatitis B (HBV)/HIV-coinfection
- Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices
- Neutropenia (\<1500/ul), thrombocytopenia (\<70/nl), anemia (\<12g/dl in females, \<13g/dl in males)
- History of autoimmune disease
- History of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00136318
Start Date
January 1 2004
End Date
September 1 2008
Last Update
March 21 2013
Active Locations (1)
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1
Department of Gastroenterolgy and Rheumatology, Sektion Hepatology
Leipzig, Germany, 04103