Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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,...)