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

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Escitalopram (Drug); Placebo (Drug); Peginterferon alfa-2a (Drug); Ribavirin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Thomas Berg, Prof. Dr., Study Chair, Affiliation: Charité
Martin Schaefer, Prof. Dr., Study Chair, Affiliation: Charite University, Berlin, Germany

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 Details

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.

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

Primary outcome: Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher

Secondary outcome:

Proportion of Patients Without 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 Defined as a MADRS Score of 25 or Higher

Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)

Sustained Virologic Response

Tolerability

Safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Gastroenterolgy and Rheumatology, Sektion Hepatology, Leipzig 04103, Germany
Additional Information

Starting date: January 2004
Last updated: March 20, 2013

Page last updated: August 23, 2015

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