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

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. Identifier: NCT00408304
Recruitment Status : Unknown
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : December 6, 2006
Last Update Posted : December 6, 2006
Information provided by:
Bnai Zion Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: omega-3 fatty acid Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Study Start Date : December 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
  2. with the BDI questionnaire which estimates the level of depression of the patient and
  3. 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 :
  1. Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
  2. albumin
  3. bilirubin
  4. ALT
  5. CRP
  6. hemoglobin
  7. WBC
  8. platelets

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

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.

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 identifier (NCT number): NCT00408304

Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Elad Schiff    97248359281   
Principal Investigator: Elad Schiff         
Sponsors and Collaborators
Bnai Zion Medical Center
Principal Investigator: Elad Schiff, MD affiliated with Bnai Zion MC Identifier: NCT00408304     History of Changes
Other Study ID Numbers: Schiff1
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: December 6, 2006
Last Verified: December 2006

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

Additional relevant MeSH terms:
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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs