Phase 3
Completed N=181
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Source: ClinicalTrials.gov NCT00136318 ↗Enrolled (actual)
181
Serious AEs
5.5%
Results posted
Mar 2013
Primary outcomePrimary: Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher — 32; 59 percentage of participants
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,...)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher |
32; 59 | — |
| SECONDARY Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher) |
60; 40 | — |
| SECONDARY Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria |
8; 17 | — |
| SECONDARY Severe Depression Defined as a MADRS Score of 25 or Higher |
1; 12 | — |
| SECONDARY Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36) |
— | — |
| SECONDARY Sustained Virologic Response |
56; 46 | — |
| SECONDARY Tolerability |
— | — |
| SECONDARY Safety |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00136318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.