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,...)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
208
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.
Department of Gastroenterolgy and Rheumatology, Sektion Hepatology
Leipzig, Germany
Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores \> 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)
Time frame: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3
Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)
Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression
Time frame: Patients free of depression during 24 or 48 weeks of antiviral therapy
Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria
Time frame: major depression during 24 or 48 weeks of antiviral therapy
Severe Depression Defined as a MADRS Score of 25 or Higher
Time frame: severe depression during 24 or 48 weeks of antiviral therapy
Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)
Time frame: assessed 2,4,12,24 and 48 weeks of antiviral treatment
Sustained Virologic Response
(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)
Time frame: assessed 24 weeks after end of antiviral treatment
Tolerability
Time frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
Safety
Time frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.