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S-Citalopram for the Prevention of PEGASYS-Induced Depression

This study is ongoing, but not recruiting participants.

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 (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)

Condition Intervention Phase
Depression
Drug: S-citalopram
Phase III

MedlinePlus related topics:   Depression    Hepatitis    Hepatitis C   

ChemIDplus related topics:   Ribavirin    Peginterferon Alfa-2a    Escitalopram    Benzetimide    Citalopram    Citalopram hydrobromide    Dexetimide    Escitalopram oxalate    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

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 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 as provided by Charite University, Berlin, Germany:

Estimated Enrollment:   200
Study Start Date:   January 2004
Estimated Study Completion Date:   December 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
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
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136318

Locations
Germany
Charité Campus Virchow-Klinikum, Hepatology and Gastroenterology    
      Berlin, Germany, 13353

Sponsors and Collaborators
Charite University, Berlin, Germany

Investigators
Study Chair:     Thomas Berg, PD Dr.     Charité    
Study Chair:     Martin Schäfer, PD Dr.     Charité Berlin    
  More Information

Study ID Numbers:   ML18075
First Received:   August 26, 2005
Last Updated:   July 24, 2006
ClinicalTrials.gov Identifier:   NCT00136318
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Pegasys-Induced depression  

Study placed in the following topic categories:
Interferon-alpha
Depression
Hepatitis, Chronic
Interferons
Ribavirin
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms
Hepatitis
Mental Disorders
Mood Disorders
Peginterferon alfa-2a
Hepatitis C
Dexetimide
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:
Anti-Infective Agents
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Antiviral Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on August 28, 2008




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