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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06746857
Eligibility Criteria:
Inclusion Criteria:
1. are assigned female sex at birth;
2. are 16yo to 24yo;
3. outpatients;
4. are competent to assent (those age 16-18) or consent to participate (those age 19-24);
5. have a Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM 5) diagnosis of Major Depressive Episode by Mini-International Neuropsychiatric Interview (MINI) version 7.0.0 for participants aged 18-24 and Adolescents (MINI-KID) for participants aged 16-17;
6. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item) or Depressive symptom severity as shown by a total Children's Depression Rating Scale Revised (CDRS-R) score 40;
7. have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;
8. are able to adhere to the treatment schedule;
9. pass both the TMS and MRI adult safety screening questionnaires.
Exclusion Criteria:
1. have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;
2. have a concomitant major unstable medical illness;
3. have active suicidal intent;
4. have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form
5. are pregnant or planning to become pregnant during the study period;
6. have a lifetime (MINI) diagnosis of any psychotic disorder;
7. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;
8. have previously had ECT or rTMS;
9. have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.
10. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
11. have history of epilepsy
12. are participating in standardized regular psychotherapy provided by a psychiatrist or a registered psychologist for less than 3 months prior to study entry or planning to start during the course of rTMS treatments;
13. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT06746857
Study Brief:
Protocol Section:
NCT06746857