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N/ACompleted
Drug / intervention
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Search/NCT00001547
NCT00001547N/ACompleted

A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines

National Institute of Mental Health (NIMH)·observational·Posted Nov 4, 1999·Updated Mar 4, 2008

In Brief

An observational study for Mental Disorder. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMental Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartJun 1, 1996
Study CompletionJun 1, 2002
TodayJul 2, 2026
Posted 26.7 years ago