Completed

All Genders
ID00001547

A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines

Led by National Institute of Mental Health (NIMH) · Updated on 2008-03-04

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neuropsychiatric Effects of Interferon-Alpha and Ribavirin

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States, 20892

Status Unknown

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial