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

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,...)

Timeline

Start

2004-01

Primary completion

2008-09

Completion

2008-09

Publications

• Sarkar S, Sarkar R, Berg T, Schaefer M. Sadness and mild cognitive impairment as predictors for interferon-alpha-induced depression in patients with hepatitis C. Br J Psychiatry. 2015 Jan;206(1):45-51. doi: 10.1192/bjp.bp.113.141770. Epub 2014 Oct 30.
• Schaefer M, Sarkar R, Knop V, Effenberger S, Friebe A, Heinze L, Spengler U, Schlaepfer T, Reimer J, Buggisch P, Ockenga J, Link R, Rentrop M, Weidenbach H, Fromm G, Lieb K, Baumert TF, Heinz A, Discher T, Neumann K, Zeuzem S, Berg T. Escitalopram for the prevention of peginterferon-alpha2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. Ann Intern Med. 2012 Jul 17;157(2):94-103. doi: 10.7326/0003-4819-157-2-201207170-00006.

Drugs

Indications