Mental Disorder Clinical Trial
Official title:
A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines
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 confusion.
The NIDDK is conducting a research study called, "Combination of Alpha Interferon with Long
Term Ribavirin Therapy for Patients with Chronic Hepatitis C" (98-DK-0003). Patients
participating in it are receiving interferon-alpha in addition to an antiviral medication
called ribavirin. Researchers at the NIMH intend to study patients to learn more about how
different medications can influence mood, thoughts and behavior.
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 (MRS).
MRS uses strong magnetic fields in order to measure biochemical products of metabolism found
in the brain. Researchers intend to perform MRS scans before, during, and after patients
receive their medications
Researchers believe that the combination of IFN-A/Ribavirin will directly affect specific
areas of the brain and as a result, some patients will develop specific mood or cognitive
symptoms. Patients often must stop taking these medications because of the side effects.
This study will not contribute directly to the treatment of patient's Hepatitis C condition.
However, the information gathered from this study will help researchers better understand
the neuropsychiatric affects associated with interferon alpha and ribavirin therapy.
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 followed prospectively with the specific aim of
identifying the emergence of central nervous system (CNS) effects. The principal outcome
measures will be as follows: determinations of specific brain metabolites as measured by
proton magnetic resonance spectroscopy (1H-MRS), a brief, non-invasive, and minimal risk
procedure; ratings of mood, cognitive, and behavioral symptoms.
The hypotheses being tested in this study are as follows:
1. Treatment with IFN-A/ribavirin will decrease measures of neuronal integrity (NAA/CRE
ratio) in a brain region specific fashion.
2. The degree of change in NAA/CRE in certain brain regions (e.g. prefrontal cortex) will
correspond to the development of mood or cognitive symptoms.
The questions being asked in this study are relevant to the clinical management of HCV
patients, since adverse neuropsychiatric effects of IFN-A and ribavirin frequently
complicate protocol participation and occasionally result in a subject being taken off
protocol. There are no anticipated number of patient days per year required for this study,
as all participants will be simultaneously enrolled in NIDDK protocol 98-DK-0003.
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