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

Paul E. Croarkin

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01502033

11-004500

Details and patient eligibility

About

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.

Full description

This study aims to:

1. Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
2. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.
3. Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

Enrollment: 10 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Transcranial Magnetic Stimulation

Experimental group

Description:

Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.

Treatment:

Device: Transcranial Magnetic Stimulation