Neuropsychiatric Effects of Interferon-Alpha and Ribavirin

NCT00001547 | Completed

• 2 other identifiers: 96010396-M-0103
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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, 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

Mental Disorder

Keywords

Drug; Imaging; Brain; Metabolism; Organic Mental Syndrome; Magnetic Resonance Imaging; Spectroscopy; Neuropsychiatric Disorders; Drug Effects; Interferon-alpha

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Trzepacz PT. The neuropathogenesis of delirium. A need to focus our research. Psychosomatics. 1994 Jul-Aug;35(4):374-91. doi: 10.1016/S0033-3182(94)71759-X.

  PMID: 7916159 BACKGROUND

• Dager SR, Steen RG. Applications of magnetic resonance spectroscopy to the investigation of neuropsychiatric disorders. Neuropsychopharmacology. 1992 Jun;6(4):249-66.

  PMID: 1632893 BACKGROUND

• Ross BD, Jacobson S, Villamil F, Korula J, Kreis R, Ernst T, Shonk T, Moats RA. Subclinical hepatic encephalopathy: proton MR spectroscopic abnormalities. Radiology. 1994 Nov;193(2):457-63. doi: 10.1148/radiology.193.2.7972763.

  PMID: 7972763 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 1, 1996
• Study Completion: June 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-06

Locations

US (1)