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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT03845504
Eligibility Criteria:
Inclusion Criteria:
* 10 participants ages 12-21 years of age
* with at least moderate to severe depressive symptoms confirmed by the Children's Depression Rating Scale-Revised (CDRS-R\>40) or Hamilton Rating Scale for Depression (HRSD-17 ≥ 18)
* able to commit to protocol schedule and provide Informed consent by a legal guardian and assent by a youth participant
* have had at least one prior antidepressant treatment failure with adequate dose and duration
Exclusion Criteria:
* prior neurological diagnosis (neurodevelopmental disorders, strokes/traumatic brain injuries, brain tumor, epilepsy)
* contraindications for TMS or MRI e.g. have any implanted metal
* unstable medical conditions
* acute suicide risk, defined as an attempt in past 6 months that required medical treatment, or history of ≥2 suicide attempts in the past 12 months, or has a clear cut plan for suicide
* pregnancy, suspected pregnancy or not on birth control if sexually active; 6) Inability to locate and quantify a motor threshold
* any factor that the PI determines to be reason for exclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT03845504
Study Brief:
Protocol Section:
NCT03845504