Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Condition: Depression
MeSH terms: Hepatitis C; Depression; Depressive Disorder
Intervention: Escitalopram; Placebo; Peginterferon alfa-2a; Ribavirin
Intervention description: 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.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pegasys-Induced depression

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,...)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum
             HCV-RNA >1000 IU/ml, naive to antiviral treatment

          -  age >18 years

        Exclusion Criteria:

          -  Antidepressive treatment within the last 3 years

          -  Psychiatric diseases including major depressive disorders in past medical history

          -  Active substance abuse during the last 12 months

          -  Pregnancy, lactation, wish to become pregnant

          -  Hepatitis B (HBV)/HIV-coinfection

          -  Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal
             varices

          -  Neutropenia (<1500/ul), thrombocytopenia (<70/nl), anemia (<12g/dl in females, <13g/dl
             in males)

          -  History of autoimmune disease

          -  History of organ transplantation, concomitant liver disease, severe cardiopulmonary
             disease, hemolytic anemia, malignant disease