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

Condition(s) targeted: Chronic Hepatitis C

Intervention: omega-3 fatty acid (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bnai Zion Medical Center

Official(s) and/or principal investigator(s):
Elad Schiff, MD, Principal Investigator, Affiliation: affiliated with Bnai Zion MC

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.

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

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

Primary outcome:

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.

Secondary outcome:

Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:

albumin

bilirubin

ALT

CRP

hemoglobin

WBC

platelets

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Bnai Zion Medical Center, Haifa, Israel; Recruiting
Elad Schiff, Phone: 97248359281, Email: eschiff@email.arizona.edu
Elad Schiff, Principal Investigator

Starting date: December 2006
Ending date: December 2007
Last updated: December 5, 2006