Neuropsychiatric Effects of Interferon-Alpha and Ribavirin

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Keywords

ClinConnect Summary

The systemic administration of interferon-alpha (IFN-A) is associated with frequent and well characterized neuropsychiatric toxicity. The primary purpose of this study is to determine if treatment with IFN-A in combination with ribavirin alters human brain biochemistry as measured by proton magnetic resonance spectroscopy. The study population will be drawn from subjects simultaneously enrolled in a NIDDK protocol (98-DK-0003) that employs IFN-A and ribavirin for the treatment of hepatitis C virus (HCV) infection. Subjects will be evaluated prior to IFN-A/ribavirin treatment and then follow...

Gender

ALL

Eligibility criteria

• • Subjects must be at least 18 years of age.
• • Subjects eligible for this study will be those enrolled in NIDDK protocol 98-DK-0003 and consequently at increased risk for the development of neuropsychiatric toxicity.
• • Subjects must be able to provide informed consent.
• • No individuals who are critically ill or markedly agitated or confused.
• • No individuals with implanted cardiac pacemakers or autodefibrillators.
• • No individuals with implanted neural pacemakers.
• • No individuals with CNS aneurysmal clips.
• • No individuals with cochlear implants.
• • No individuals with metallic foreign bodies in the eye or CNS.
• • No individuals with any form of implanted wire or metal device which may concentrate radiofrequency fields.
• • No pregnant women.
• • No individuals with a history of moderate to severe claustrophobia.