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

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: omega-3 fatty acid	Phase II

MedlinePlus related topics:

Depression Hepatitis Hepatitis C

Drug Information available for:

Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2007

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408304

Locations


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

Sponsors and Collaborators

Bnai Zion Medical Center

Investigators


Principal Investigator:	Elad Schiff, MD	affiliated with Bnai Zion MC

More Information

Study ID Numbers:	Schiff1
First Received:	December 5, 2006
Last Updated:	December 5, 2006
ClinicalTrials.gov Identifier:	NCT00408304
Health Authority:	Israel:Institutional Review Board

Keywords provided by Bnai Zion Medical Center:

interferon alpha

depression

omega 3

Study placed in the following topic categories:

Interferon-alpha

Liver Diseases

Depression

Hepatitis, Chronic

Interferons

Hepatitis, Viral, Human

Depressive Disorder

Behavioral Symptoms

Hepatitis

Virus Diseases

Digestive System Diseases

Mental Disorders

Mood Disorders

Hepatitis C

Interferon Alfa-2a

Interferon Alfa-2b

Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Flaviviridae Infections

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Antiviral Agents

Angiogenesis Inhibitors

Pharmacologic Actions

Therapeutic Uses

Angiogenesis Modulating Agents

Growth Inhibitors

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Bnai Zion Medical Center
Information provided by:	Bnai Zion Medical Center
ClinicalTrials.gov Identifier:	NCT00408304