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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00408304
• Other study ID #: Schiff1
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2006
• Last updated: December 5, 2006
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2006
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• omega-3 fatty acid

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
Primary	with the BDI questionnaire which estimates the level of depression of the patient and
Primary	the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.
Secondary	Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
Secondary	albumin
Secondary	bilirubin
Secondary	ALT
Secondary	CRP
Secondary	hemoglobin
Secondary	WBC
Secondary	platelets