Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

NCT02586688 | Completed Results DMC

• 1 other identifier: 44-02219-000
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 13

Brief Summary

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

child depression; depression; Transcranial Magnetic Stimulation; Adolescent Major Depressive Disorder; TMS; adolescent depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.

  The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)

  6 weeks

Study Arms (2)

Phase I TMS Active

ACTIVE COMPARATOR

Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

Phase I TMS Sham

SHAM COMPARATOR

Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Interventions

Active NeuroStar® Transcranial Magnetic Stimulation (TMS) DEVICE

Compare active NeuroStar® coil with sham NeuroStar® coil.

Also known as: TMS, NeuroStar®

Phase I TMS Active

Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) DEVICE

Compare active NeuroStar® coil with sham NeuroStar® coil.

Also known as: TMS, NeuroStar®

Phase I TMS Sham

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
• Duration of current episode of depression ≥4 weeks and ≤3 years
• Clinical Global Impression - Severity of Illness ≥ 4
• Resistance to antidepressant treatment in a discrete illness episode
• HAMD24 Item 1 ≥ 2 and total score ≥ 20
• Subjects able to commit to protocol visit schedule
• At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit

You may not qualify if:

• Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)
• Contraindication to TMS
• Cardiac pacemakers, implanted medication pumps, intracardiac lines
• History of neurological disorder
• Unstable medical conditions
• Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.
• Significant acute suicide risk
• Inability to locate and quantify a motor threshold
• If sexually active female, not on an accepted method of birth control.
• Diagnoses of the following conditions (current unless otherwise stated):
• Depression secondary to a general medical condition, or substance induced:
• Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,
• Intellectually disabled,
• Substance dependence or abuse within the past year (except nicotine or caffeine),

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (13)

Dothan Behavioral Medicine

Dothan, Alabama, 36303, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Rocky Mountain TMS

Grand Junction, Colorado, 81501, United States

Location

Florida Clinical Practice Association, Inc.

Gainesville, Florida, 32606, United States

Location

Anchor Neuroscience

Pensacola, Florida, 32502, United States

Location

Beacon Medical Group

South Bend, Indiana, 46601, United States

Location

Integrative Psychiatry

Louisville, Kentucky, 40222, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

• O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.

  PMID: 17573044 RESULT

• Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. doi: 10.1002/da.21969. Epub 2012 Jun 11.

  PMID: 22689344 RESULT

• Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.

  PMID: 21951987 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Neuronetics

steve.erickson@neurostar.com

16123067393

Study Officials

• Paul Croarkin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Karen Heart

  Neuronetics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)