S-Citalopram for the Prevention of PEGASYS-Induced Depression
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: S-citalopram (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Thomas Berg, PD Dr., Study Chair, Affiliation: Charité
Martin Schäfer, PD Dr., Study Chair, Affiliation: Charité Berlin
Summary
Primary Endpoints
- 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. The occurrence of moderate to severe depression is measured by the
Hamilton Depression Rating Scale 24 weeks after starting interferon therapy.
Secondary Endpoints
- Quality of life (SF-36)
- Drop-out rate
- Biochemical response defined by serum glutamyl pyruvic transaminase (GPT) values 24
weeks after treatment
- Virological response measured by HCV-RNA at the end of treatment and after six months of
treatment
- Predictive parameters for patients especially gaining from an antidepressive therapy
(e. g. age, gender, weight, height, alanine aminotransferase [ALT] quotient defined as
median ALT values before treatment divided by the upper standard value, gamma-glutamyl
transpeptidase [GGT], HCV-RNA serum concentration level of fibrosis in liver histology,
baseline values of the different psychometric scales)
- Comparison of safety placebo versus verum (from psychiatric and hepatological view)
Clinical Details
Official title: Comparison of the Tolerability of a Treatment Over 24- or 48 Weeks With Pegylated Interferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C With or Without Antidepressive Escitalopram Pre- and Concomitant Treatment
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
- All HCV genotypes
- Patients must be willing and able to adhere to dosing and visit schedules
Exclusion Criteria:
- Antidepressive treatment within the last 3 years
- Psychiatric diseases in past medical history
- Active substance abuse
- 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
Charité Campus Virchow-Klinikum, Hepatology and Gastroenterology, Berlin 13353, Germany
Additional Information
Starting date: January 2004
Ending date: December 2005
Last updated: July 24, 2006
|
