Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Phase 2
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00408304
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of: albumin bilirubin ALT CRP hemoglobin WBC platelets
Trial Locations
- Locations (1)
Bnai Zion Medical Center
🇮🇱Haifa, Israel