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Clinical Trial Name - S-Citalopram for the Prevention of PEGASYS-Induced Depression

 
Original Study ID : ML18075
NCT ID : NCT00136318
Brief Title : S-Citalopram for the Prevention of PEGASYS-Induced Depression
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
Brief 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)

Source : Charite University, Berlin, Germany
Overall Status : Active, not recruiting
Start Date : January 2004
End Date : December 2005
Completion Date : December 2005
Official Title : Phase 3
Phase : Interventional
Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Enrollment : 200
Verification Date : August 2005
First Received Date : August 26, 2005
Trial 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

- 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
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Facilities
Facility Name : Charité Campus Virchow-Klinikum, Hepatology and Gastroenterology
City : Berlin
Zip Code : 13353
Country : Germany
Interventions
Type : Drug
Name : S-citalopram
 
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