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Phase II Open Label Active TMS for Depression

N/A
Waitlist Available
Led By Paul Croarkin, MD
Research Sponsored by Neuronetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study 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).

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase III Long-Term Follow up TMS ActiveExperimental Treatment1 Intervention
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Group II: Phase II Open Label Active TMSExperimental Treatment1 Intervention
Open label active TMS coil. Open label active NeuroStar® TMS.
Group III: Phase I TMS ActiveActive Control1 Intervention
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Group IV: Phase I TMS ShamPlacebo Group1 Intervention
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Find a Location

Who is running the clinical trial?

NeuroneticsLead Sponsor
22 Previous Clinical Trials
7,452 Total Patients Enrolled
12 Trials studying Depression
7,027 Patients Enrolled for Depression
Paul Croarkin, MDPrincipal InvestigatorMayo Clinic
Karen HeartStudy DirectorNeuronetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of Clinical PsychiatryJournal
Adjunctive Use of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents
Wall, Christopher A., Paul E. Croarkin, Leslie A. Sim, Mustafa M. Husain, Philip G. Janicak, F. Andrew Kozel, Graham J. Emslie, Sheila M. Dowd, and Shirlene M. Sampson. 2011. “Adjunctive Use of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.11m07003.
Depression and AnxietyJournal
Transcranial Magnetic Stimulation (tms) for Major Depression: A Multisite, Naturalistic, Observational Study of Acute Treatment Outcomes in Clinical Practice
Carpenter, Linda L., Philip G. Janicak, Scott T. Aaronson, Terrence Boyadjis, David G. Brock, Ian A. Cook, David L. Dunner, Karl Lanocha, H. Brent Solvason, and Mark A. Demitrack. 2012. “Transcranial Magnetic Stimulation (tms) for Major Depression: A Multisite, Naturalistic, Observational Study of Acute Treatment Outcomes in Clinical Practice”. Depression and Anxiety. Wiley. doi:10.1002/da.21969.
Biological PsychiatryJournal
Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial
O’Reardon, John P., H. Brent Solvason, Philip G. Janicak, Shirlene Sampson, Keith E. Isenberg, Ziad Nahas, William M. McDonald, et al.. 2007. “Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2007.01.018.
clinicaltrials.govStudy
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
2015. "Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02586688.
All > Transcranial Magnetic Stimulation
~10 spots leftby May 2025
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