| 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 |
| Search Trials By |
| Research |
| Most Popular Trials |
| Library |
| Discuss |