Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression.

Key facts

Study ID

NCT01502033

Run by

Paul E. Croarkin

People needed

10

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2016-04-22

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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