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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04502758
Eligibility Criteria:
Inclusion Criteria:
* Inpatients or outpatients
* Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent
* Female or male
* 12-18 years of age
* Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117
* In a current episode of MDD with duration of at least 4 weeks but less than 3 years
* Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109
* Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more
* Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104
* On a medically acceptable form of birth control if female
* Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations.
Exclusion Criteria:
* Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
* Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123
* Positive urine drug screen at baseline
* Seizure history
* Any family history of epilepsy
* History of any treatment with electroconvulsive therapy or TMS
* Use of any investigational drug within 4 weeks of baseline
* Prior brain surgery
* Risk for increased intracranial pressure such as a brain tumor
* Head trauma with loss of consciousness
* Any true positive findings on the TMS safety screening form
* Pregnancy or suspected pregnancy
* Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).
* Implanted medication pumps and cardiac pacemakers
* Any unstable medical condition
* Inability to adhere to the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04502758
Study Brief:
Protocol Section:
NCT04502758