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

This study is currently recruiting participants.

Verified by Bnai Zion Medical Center, December 2006

First Received: December 5, 2006 No Changes Posted

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Depression Hepatitis Hepatitis C

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Interferon alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Bnai Zion Medical Center:

interferon alpha
depression
omega 3

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hepatitis, Viral, Human
Mental Disorders
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon-alpha
RNA Virus Infections

Depression
Growth Substances
Interferons
Depressive Disorder
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Virus Diseases
Hepatitis
Digestive System Diseases
Mood Disorders
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 11, 2009