Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001547
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Neuropsychiatric Effects of Interferon-Alpha and Ribavirin
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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-ARibavirin 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 patients 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 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-ARibavirin 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 patients 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
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 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-Aribavirin 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-Aribavirin will decrease measures of neuronal integrity NAACRE ratio in a brain region specific fashion
2 The degree of change in NAACRE in certain brain regions eg 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
The hypotheses being tested in this study are as follows
1 Treatment with IFN-Aribavirin will decrease measures of neuronal integrity NAACRE ratio in a brain region specific fashion
2 The degree of change in NAACRE in certain brain regions eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-M-0103 | None | None | None |