S-Citalopram for the Prevention of PEGASYS-Induced Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

July 24, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00136318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

S-Citalopram for the Prevention of PEGASYS-Induced Depression

Official Title ^ICMJE

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)

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: S-citalopram

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

200

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00136318

Responsible Party

Study ID Numbers ^ICMJE

ML18075

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Charite University, Berlin, Germany

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP