Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Sep 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a potential treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition that causes extreme fatigue and other symptoms without a clear cause or effective treatments. The researchers are looking at how a drug called N-Acetylcysteine (NAC) may help improve brain function and reduce stress in the body by restoring certain protective levels of a substance called glutathione (GSH). They want to see if different doses of NAC can help patients with ME/CFS compared to a placebo, which is a substance with no active ingredients.

To participate in the trial, individuals must be between 21 and 60 years old and have a confirmed diagnosis of ME/CFS with specific baseline GSH levels. Participants also need to be able to give their consent and not have certain other medical conditions or recent substance use that could interfere with the study. If you join, you will receive either NAC or a placebo and undergo assessments to monitor your health and symptoms. This trial is important as it could lead to new treatments for ME/CFS, a condition that currently lacks validated options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females, ages 21 to 60 years (inclusive).
• • Baseline GSH levels at or less than a predefined cutoff value.
• • Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
• • Willing and capable of providing informed consent.
• Exclusion Criteria:
• • Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders.
• • Any significant neurological illness or impairment.
• • Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc).
• • History alcohol abuse.
• • Positive urine toxicology at screening and on days of assessments.
• • Positive pregnancy test at screening or on days of assessments.
• • Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis).
• • Baseline GSH levels higher than a predefined cutoff value.