S-Citalopram for the Prevention of PEGASYS-Induced Depression - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Depression Hepatitis Hepatitis C

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Peginterferon Alfa-2a Escitalopram oxalate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Charite University, Berlin, Germany:

Pegasys-Induced depression

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
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Dexetimide

Antidepressive Agents
Depression
Depressive Disorder
Antiviral Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peginterferon alfa-2a
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009