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

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Drug: Escitalopram; Drug: Ribavirin; Drug: Peginterferon alfa-2a; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00136318

ML18075

Details and patient eligibility

About

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,...)

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups, including a placebo group

Escitalopram

Active Comparator group

Description:

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Treatment:

Drug: Escitalopram

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Placebo

Placebo Comparator group

Description:

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Treatment:

Drug: Placebo

Drug: Ribavirin

Drug: Peginterferon alfa-2a