At a glance
ClinicalIndex Comparison Record- ✓Chronic hepatitis C infection confirmed by positive anti-HCV antibodies and serum HCV-RNA >1000 IU/ml
- ✓Age >18 years
- ✓Naive to antiviral treatment for HCV
- ✕Any antidepressive medication within the last 3 years
- ✕Psychiatric diseases including major depressive disorder in past medical history
- ✕Active substance abuse during the last 12 months
- ✕Pregnancy or lactation, or plans to become pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial.
In Brief
A Phase 3 clinical trial evaluating Escitalopram, Placebo, and 2 other interventions for Depression. Completed, enrolled 208 participants across 1 site.
Detailed 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,...)
Study Details
Timeline
Interventions
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.