Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale

Secondary end points

• time to depression defined as a MADRS score of 13 or higher

• incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria

• severe depression according to MADRS scale (score 25 or higher)

• Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)

• sustained virologic response

• tolerability

• safety

• changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)

Other investigations:

• cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)

• Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)

• alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)

• biomarkers (genetic parameters, cytokines,...)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Citalopram; Dexetimide; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

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