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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02948556
Eligibility Criteria:
Inclusion Criteria:
Fukuda-based ME/CFS symptoms including:
* six months of unexplained, debilitating fatigue
* 4/8 secondary symptoms impaired memory or concentration unrefreshing sleep sore throats headache muscle pain joint pain tender lymph nodes post-exertional malaise
Exclusion Criteria:
Medical: fatigue clearly attributable to self-report medical conditions.
Psychiatric any psychosis alcohol/ substance abuse within two years prior or after illness onset. depression with melancholic/psychotic features within 5 years of onset .
Two other exclusionary criteria:
* patients not dose-stabilized for at least 3 months on antidepressants ;
* patients at risk of suicide or need of urgent psychiatric treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02948556
Study Brief:
Protocol Section:
NCT02948556