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

Depression Clinical Trial

Official title: 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.

Status Completed

Clinical Trial 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,...)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT00136318
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Completion date: September 2008