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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT07185451
Eligibility Criteria:
Inclusion Criteria:
1. Age 12-18 years.
2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.
3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.
4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.
Exclusion Criteria:
1. Psychiatric comorbidities other than anxiety disorders.
2. Depression with psychotic features.
3. Young Mania Rating Scale (YMRS) score \>13.
4. History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).
5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.
6. Current use of antiepileptic drugs or high-dose benzodiazepines.
7. History of alcohol or substance abuse or dependence.
8. Pregnant or breastfeeding females.
9. Contraindications to MRI.
10. Current high suicide risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07185451
Study Brief:
Protocol Section:
NCT07185451