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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01502033
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
* Pretreatment CDRS-R Raw score ≥ 40
* Age is at least 13 and less than 19 years
* Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):
* Celexa (citalopram hydrobromide) - 10 to 60mg
* Cymbalta (duloxetine) - 40mg to 120mg
* Desyrel (trazodone HCl) - 12.5mg to 150mg
* Effexor (venlafaxine HCl) - 37.5mg to 300mg
* Luvox (fluvoxamine maleate) - 25mg to 200mg
* Lexapro (escitalopram oxalate) - 10mg to 40mg
* Paxil (paroxetine HCl) - 10mg to 50mg
* Pristiq (desvenlafaxine) - 50mg to 100mg
* Prozac (fluoxetine HCl) - 10mg to 80mg
* Remeron (mirtazapine) - 7.5mg to 45mg
* Zoloft (sertraline HCl) - 25mg to 200mg
* Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester
* Willing to provide informed assent (adolescent) and informed consent (family)
Exclusion Criteria:
* Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
* Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
* Contraindication to MRI
* Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
* History of schizophrenia, schizoaffective disorder, other \[non mood disorder\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
* History of autoimmune, endocrine, viral, or vascular disorder.
* Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
* Active suicidal intent or plan, or history of attempt within the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT01502033
Study Brief:
Protocol Section:
NCT01502033