A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents
Trial status: Open for Enrollment
Why is this study being done?
Part 2 of the study aims to:
- Evaluate the benefit of daily, active, open-label rTMS in Part 1 non-responders.
- Evaluate the benefits of bi-weekly, active, open-label maintenance rTMS treatment for Part 1 responders over the course of 12 months post acute treatment.
- Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase.
- Define regional specificity [anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (i.e. glutamate and glutamine) in adolescent depression.
- Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.
Who is eligible to participate?
- Successful completion of Part 1 of study
- Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
- 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 all study visits at study site.
- Willing to provide informed assent (adolescent) and informed consent (family)
- Withdrew from treatment of study Part 1
- Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
- Prior 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