Status:
COMPLETED
Neuropsychiatric Effects of Interferon-Alpha and Ribavirin
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Mental Disorder
Eligibility:
All Genders
Brief Summary
Use of the drug interferon-alpha (IFN-A), is associated with frequent and well characterized side effects like neurotoxicity. Neurotoxicity can cause symptoms of depression, agitation, anxiety, and/or...
Detailed Description
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 wit...
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.
Key Trial Info
Start Date :
June 1 1996
Trial Type :
OBSERVATIONAL
End Date :
June 1 2002
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00001547
Start Date
June 1 1996
End Date
June 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892