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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT03986658
Eligibility Criteria:
Inclusion:
1. Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
2. Meets criteria for TRD:
1. failed two adequate courses of antidepressant medication OR
2. failed adequate course of medication AND one course of psychotherapy.
3. Score of \> 40 on Child Depression Rating Scale-Revised OR score of \> 20 on Child Depression Inventory-2.
4. Fluent in speaking and reading English.
Exclusion:
1. Positive pregnancy test.
2. Current or past: bipolar disorder, psychotic disorder, autism spectrum disorder, intellectual disability, substance use disorder, conduct disorder, as determined by a structured psychiatric interview.
3. Medical illness that could lower the seizure threshold, e.g., epilepsy from any cause.
4. Medications that could lower the seizure threshold or affect brain function.
5. Psychotropic medications changed in two weeks prior to enrollment.
6. Fails the TMS safety screening questionnaire.
7. Fails fMRI screening process.
8. Left-handed (may indicate different cortical lateralization which could affect outcomes).
9. Involuntarily committed to the hospital.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
17 Years
Study:
NCT03986658
Study Brief:
Protocol Section:
NCT03986658