Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement
Weill Medical College of Cornell University
Summary
Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.
Description
This phase two, single-site study will utilize a double-blind, placebo-controlled, randomized, pre-/post-treatment design to investigate the effect of NAC dosing on brain GSH levels and measure temporally concordant plasma levels of several established circulating markers of oxidative stress. Three study groups, of 20 subjects each (for a total of 60 who completed all components of the study), will each be administered a different dose (0 mg/day, 900mg/day, 3600mg/day) of the study intervention over a four week period; N-acetylcysteine (NAC) treatment. Subjects receiving 0 mg/day dose will be…
Eligibility
- Age range
- 21–60 years
- Sex
- All
- Healthy volunteers
- No
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 scree…
Interventions
- DrugNAC 900mg/day
self administer NAC 900mg/day caplets for a four week period
- DrugNAC 3600mg/day
self administer NAC 3600mg/day caplets for a four week period
- DrugNAC 0mg/day (Placebo)
self administer NAC 0mg/day (placebo) caplets for a four week period
Location
- Weill Cornell MedicineNew York, New York