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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00408304
Enrollment
60
Registered
2006-12-06
Start date
2006-12-31
Completion date
2007-12-31
Last updated
2006-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

interferon alpha, depression, omega 3

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.

Interventions

DRUGomega-3 fatty acid

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
ALT
CRP
Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
WBC
platelets
hemoglobin
albumin
bilirubin

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026