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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03523767
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers, male or female; aged 18-65
* Subjects with history of Major depression (currently asymptomatic - symptom free for more than 6 months)
* Medication free, if not feasible being on antidepressants will be allowed
Exclusion Criteria:
* Volunteers who received this vaccine within 3 years or any other vaccine within 3 months
* Patients with existing inflammatory conditions (connective tissue disorder, autoimmune conditions, neoplastic disease, chronic infections, etc.)
* Patients with acute viral or bacterial infection
* Hospitalized patients
* Patients in acute phase of illness
* Current active medical condition that affect brain anatomy, neurochemistry, or function, e.g. liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases)
* History of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and serious head injury with loss of consciousness
* Family history of hereditary neurologic disorder
* Floating metallic objects in the body
* Pregnancy
* Exposure to regular use of anti-inflammatory drugs in the last one month
* Excessive exercise, consumption of caffeinated beverages or alcohol, high-fat meals 12 hours before testing
* History of tobacco, alcohol, or drug abuse or dependence.
* History of allergic reaction to vaccination or serious allergic reaction to shellfish or egg allergy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03523767
Study Brief:
Protocol Section:
NCT03523767