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

NCT01502033 | Completed Results DMC

• 1 other identifier: 11-004500
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Adolescent Depression; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

  The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.

  5 days of Treatment 30 or Last Treatment

Secondary Outcomes (2)

• Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

  Within 5 days of Treatment 30 or Last Treatment

• The Clinical Global Impression - Improvement (CGI-I)

  Within 5 days of 30 treatments or after last treatment in case of early withdrawal

Study Arms (1)

Transcranial Magnetic Stimulation

EXPERIMENTAL

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.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment

Also known as: NeuroStar

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

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

Sponsors & Collaborators

• Paul E. Croarkin: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 24376426 BACKGROUND

• 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.

  PMID: 31634515 DERIVED

• 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.

  PMID: 26849202 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Please note that clinical results must be interpreted with caution due to small sample size and study design.

Results Point of Contact

• Title: Dr. Paul Croarkin
• Organization: Mayo Clinic

croarkin.paul@mayo.edu

(507) 293-2557

Study Officials

• Paul E Croarkin, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 30, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 22, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)