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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408304
First Posted: December 6, 2006
Last Update Posted: December 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bnai Zion Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00408304     History of Changes
Other Study ID Numbers: Schiff1
First Submitted: December 5, 2006
First Posted: December 6, 2006
Last Update Posted: December 6, 2006
Last Verified: December 2006

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

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