Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT04542161
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT04542161
Study Brief:
Protocol Section:
NCT04542161