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

This study is currently recruiting patients.
Verified by Charite University, Berlin, Germany August 2005

Sponsored by: Charite University, Berlin, Germany
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00136318

Purpose

Primary Endpoints

  • Effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram on frequency and severity of depression in patients with chronic hepatitis C treated with Peg-interferon alfa 2a 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 GPT values 24 weeks after treatment Virological response measured by HCV-RNA at the end of treatment and after six month of treatment
  • Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, ALT quotient defined as median ALT values before treatment divided by the upper standard value, 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)
Condition Intervention Phase
Pegasys-Induced depression
 Drug: S-Citalopram
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Comparison of the Tolerability of a Treatment Over 24- or Rather 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

Further Study Details: 

Expected Total Enrollment:  200

Study start: January 2004;  Expected completion: December 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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
  • 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 cardiopulmonal disease, hemolytic anemia, malignant disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136318

Thomas Berg, PD Dr.      +4930450553072    thomas.berg@charite.de

Germany
      Charité Campus Virchow-Klinikum, Hepatology and Gastroenterology, Berlin,  13353,  Germany; Recruiting
Thomas Berg, PD Dr.  +4930450553072    thomas.berg@charite.de 
Thomas Berg, PD Dr.,  Principal Investigator

Study chairs or principal investigators

Thomas Berg, PD Dr.,  Study Chair,  Charité   

More Information

Study ID Numbers:  ML18075
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00136318
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-30



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