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NCT00001547 · ClinicalTrials.gov registry record

Neuropsychiatric Effects of Interferon-Alpha and Ribavirin

A clinical trial of Mental Disorder, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
150
Enrollment target
1
Study location

NCT00001547 is a study of Mental Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 150 participants, below the 318-participant average among 21 other Mental Disorder trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001547, a study of Mental Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
150 participants
Enrollment target
1
Study location

Study 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 Studied

Study Locations (1)

Maryland

  • National Institute of Mental Health (NIMH) - Bethesda

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 1996-06
Est. Completion 2002-06

What the Registry Record Tells You About NCT00001547

The ClinicalTrials.gov registry entry for NCT00001547 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 318-participant average among 21 other Mental Disorder trials with a reported enrollment target (53% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mental Disorder appearing as the primary indexed condition, and to 0 interventions.

NCT00001547 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001547 about?

NCT00001547 is a clinical study titled "Neuropsychiatric Effects of Interferon-Alpha and Ribavirin". 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 ...

What is the current status of trial NCT00001547?

This trial is currently completed. The enrollment target is 150 participants. The study started on 1996-06. Estimated completion is 2002-06.

What conditions does trial NCT00001547 study?

This clinical trial studies the following conditions: Mental Disorder.

Who is sponsoring clinical trial NCT00001547?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001547 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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