Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression
NCT ID: NCT03363919
Last Updated: 2024-02-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
47 participants
INTERVENTIONAL
2018-09-24
2023-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression
NCT00587639
Cortical Excitability and Inhibition in MDD
NCT01718730
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
NCT01502033
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression
NCT01115699
Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms
NCT02611206
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 Hz left prefrontal rTMS
36 sessions of 1 Hz rTMS at 120% motor threshold applied to the left prefrontal cortex. Each session is 2400 continuous pulses.
NeuroStar TMS Therapy® System
The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with Major Depressive Disorder (MDD) who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.
NeuroStar XPLOR®
NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.
10 Hz left prefrontal rTMS
36 sessions of 10 Hz rTMS at 120% motor threshold applied to the left prefrontal cortex. Each session is 2400 pulses with 4 seconds on and 36 seconds off.
NeuroStar TMS Therapy® System
The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with Major Depressive Disorder (MDD) who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.
NeuroStar XPLOR®
NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NeuroStar TMS Therapy® System
The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with Major Depressive Disorder (MDD) who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.
NeuroStar XPLOR®
NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Depression symptoms severity of a 40 or greater based on evaluation with the Children's Depression Rating Scale Revised (CDRS-R) at screening and baseline visits. Further, the total score of the baseline CDRS-R score must not have had a 25% or greater decrease from the screening CDRS-R score
* The duration of the current episode of depression must be 4 weeks or more but 3 years or less.
* For any participant currently receiving antidepressant medication, the referring clinician must determine that insufficient benefit is being received from this treatment and it is clinically appropriate to discontinue the existing antidepressant.
* Participants in psychotherapy are eligible provided that this was initiated 4 weeks prior to enrollment and that the frequency of visits will be maintained during study participation.
Exclusion Criteria
* A positive urine drug screen at baseline
* Seizure history
* Family history of epilepsy in a first degree relative
* Head trauma with loss of consciousness for greater than 5 minutes
* Any true positive findings on the rTMS safety screening form.
* Any concurrent psychotropic medications (for potential participants receiving antidepressants or psychotropic medications, the referring clinician must determine that insufficient benefit is being received from the treatment and if clinically appropriate, discontinue existing antidepressants and other psychotropic medications)
* Prohibited concomitant medications (See Appendix A)
* Pregnancy or suspected pregnancy in female Participants (assessed with urine pregnancy test)
* Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the subject's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes.
* Prior brain surgery
* Risk for increased intracranial pressure such as a brain tumor
* Any unstable medical condition
* History of treatment with ECT or TMS Therapy for any disorder
* Use of any investigational drug within 4 weeks of the baseline visit
* Initiation of a new psychotherapeutic treatment within the past 4 weeks
* Suicide attempt within the previous 6 months that required medical treatment or ≥ 2 attempts in the past 12 months, or has a clear cut plan for suicide and states that he/she cannot guarantee that he/she will inform a family member or call his/her psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or, in the investigator's opinion, is likely to attempt suicide within the next 6 months.
12 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Neuronetics
OTHER
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul E. Croarkin
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul E Croarkin, DO
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Croarkin PE, Nakonezny PA, Wall CA, Murphy LL, Sampson SM, Frye MA, Port JD. Transcranial magnetic stimulation potentiates glutamatergic neurotransmission in depressed adolescents. Psychiatry Res Neuroimaging. 2016 Jan 30;247:25-33. doi: 10.1016/j.pscychresns.2015.11.005. Epub 2015 Nov 27.
Croarkin PE, Wall CA, Lee J. Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. Int Rev Psychiatry. 2011 Oct;23(5):445-53. doi: 10.3109/09540261.2011.623688.
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.
Croarkin PE, Nakonezny PA, Husain MM, Melton T, Buyukdura JS, Kennard BD, Emslie GJ, Kozel FA, Daskalakis ZJ. Evidence for increased glutamatergic cortical facilitation in children and adolescents with major depressive disorder. JAMA Psychiatry. 2013 Mar;70(3):291-9. doi: 10.1001/2013.jamapsychiatry.24.
Donaldson AE, Gordon MS, Melvin GA, Barton DA, Fitzgerald PB. Addressing the needs of adolescents with treatment resistant depressive disorders: a systematic review of rTMS. Brain Stimul. 2014 Jan-Feb;7(1):7-12. doi: 10.1016/j.brs.2013.09.012.
Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.
Delaney K, Nakonezny PA, Buyuktaskin D, Carrasco LS, Athreya AP, Romanowicz M, Shekunov J, Vande Voort JL, Croarkin PE. Trajectories of Irritability Improvement in Depressed Adolescents Treated With 1 Hz and 10 Hz Transcranial Magnetic Stimulation. J Clin Psychiatry. 2025 Apr 9;86(2):24m15684. doi: 10.4088/JCP.24m15684.
Lewis CP, Nakonezny PA, Sonmez AI, Ozger C, Garzon JF, Camsari DD, Yuruk D, Romanowicz M, Shekunov J, Zaccariello MJ, Vande Voort JL, Croarkin PE. A Dose-Finding, Biomarker Validation, and Effectiveness Study of Transcranial Magnetic Stimulation for Adolescents With Depression. J Am Acad Child Adolesc Psychiatry. 2025 Oct;64(10):1179-1191. doi: 10.1016/j.jaac.2024.08.487. Epub 2024 Sep 6.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-004958
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.