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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00408304
First received: December 5, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Bnai Zion Medical Center:
interferon alpha
depression
omega 3

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Depression
Depressive Disorder
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Behavioral Symptoms
Mood Disorders
Mental Disorders
Flaviviridae Infections
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014