Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha. - Tabular View

Tracking Information

First Received Date ^ICMJE

December 5, 2006

Last Updated Date

December 5, 2006

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
with the BDI questionnaire which estimates the level of depression of the patient and
the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
albumin
bilirubin
ALT
CRP
hemoglobin
WBC
platelets

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Official Title ^ICMJE

Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Brief Summary

The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.

Detailed Description

Omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. We assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: omega-3 fatty acid

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

Recruiting

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.

Exclusion Criteria:

Disagreement to participation in trial.
Diagnosed and active mental illness.
Encephalopathic patients.
Patients with limited ability to understand the questionnaires or the informed consent process.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00408304

Responsible Party

Study ID Numbers ^ICMJE

Schiff1

Study Sponsor ^ICMJE

Bnai Zion Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Elad Schiff, MD

affiliated with Bnai Zion MC

Information Provided By

Bnai Zion Medical Center

Verification Date

December 2006

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