A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents

Fecha de inicio: 1 de abril de 2013

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 12 and less than 22 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 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 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