Neuropsychiatric Effects of Interferon-Alpha and Ribavirin
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|ClinicalTrials.gov Identifier: NCT00001547|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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.
|Condition or disease|
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:
- Treatment with IFN-A/ribavirin will decrease measures of neuronal integrity (NAA/CRE ratio) in a brain region specific fashion.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines|
|Study Start Date :||June 1996|
|Estimated Study Completion Date :||June 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001547
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|