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

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

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