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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04370002
Eligibility Criteria:
Inclusion Criteria:
1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working smartphone and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.
9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks
Exclusion Criteria:
1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychotic disorder,
3. History of mania or hypomania,
4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Cannot comprehend or communicate in English,
11. Lack of working smartphone or lack of daily access to Internet service,
12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04370002
Study Brief:
Protocol Section:
NCT04370002