Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients (CIPPAD)
Depression
About this trial
This is an interventional prevention trial for Depression focused on measuring Pegasys-Induced depression
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Department of Gastroenterolgy and Rheumatology, Sektion Hepatology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Escitalopram
Placebo
After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.