Neuropsychiatric Effects of Interferon-Alpha and Ribavirin

March 3, 2008 updated by: National Institute of Mental Health (NIMH)

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.

Study Overview

Status

Completed

Conditions

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-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.

Study Type

Observational

Enrollment

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Mental Health (NIMH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Study Completion

June 1, 2002

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

June 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960103
  • 96-M-0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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