rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

Inclusion Criteria:

• Diagnosis of unipolar major depressive disorder, in a current major depressiveepisode, without psychotic features
• Pretreatment CDRS-R Raw score ≥ 40
• Age is at least 12 and less than 22 years
• Ongoing, stable dose antidepressant therapy for at least 6 weeks to include thefollowing 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
• Savella (milnacipran HCl) - 25mg to 200mg
• Zoloft (sertraline HCl) - 25mg to 200mg
• Subjects able to attend at least 31 study visits at study site.
• Willing to provide informed assent (adolescent) and informed consent (family)

Exclusion Criteria:

• Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressantmedications.
• Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
• Contraindication to MRI
• Contraindication to rTMS (history of neurological disorder such as seizures, increasedintracranial 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 ofthese therapies within 3 months before enrollment in the study Unstable medicationconditions such as hematological or infectious (e.g., human immunodeficiencyvirus-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, substancedependence or abuse within the past year (except nicotine), bipolar disorder,psychotic features in this or previous episodes, amnestic disorder, obsessivecompulsive 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