Clinical trial NCT01502033: Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Official title: An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Adolescent Depression
Transcranial Magnetic Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
timeFrame: 5 days of Treatment 30 or Last Treatment
Secondary outcomes:
measure: Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
timeFrame: Within 5 days of Treatment 30 or Last Treatment
measure: The Clinical Global Impression - Improvement (CGI-I)
timeFrame: Within 5 days of 30 treatments or after last treatment in case of early withdrawal
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul E Croarkin, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall CA, Croarkin PE, McClintock SM, Murphy LL, Bandel LA, Sim LA, Sampson SM. Neurocognitive effects of repetitive transcranial magnetic stimulation in adolescents with major depressive disorder. Front Psychiatry. 2013 Dec 12;4:165. doi: 10.3389/fpsyt.2013.00165. eCollection 2013.
citation: Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
citation: Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.