Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
NCT ID: NCT02586688
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2015-10-31
2018-12-31
Brief Summary
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Detailed Description
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Secondary:
To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects.
To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) .
To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase I TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Phase I TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Interventions
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Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
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Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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),
* Bipolar disorder,
* Obsessive compulsive disorder (lifetime),
* Post-traumatic stress disorder (lifetime),
* Eating disorder (lifetime).
12 Years
21 Years
ALL
No
Sponsors
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Neuronetics
OTHER
Responsible Party
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Principal Investigators
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Paul Croarkin, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Karen Heart
Role: STUDY_DIRECTOR
Neuronetics
Locations
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Dothan Behavioral Medicine
Dothan, Alabama, United States
UCLA
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Rocky Mountain TMS
Grand Junction, Colorado, United States
Florida Clinical Practice Association, Inc.
Gainesville, Florida, United States
Anchor Neuroscience
Pensacola, Florida, United States
Beacon Medical Group
South Bend, Indiana, United States
Integrative Psychiatry
Louisville, Kentucky, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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44-02219-000
Identifier Type: -
Identifier Source: org_study_id
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