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Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
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 up to 5 years
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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)
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Who is running the clinical trial?
NeuroneticsLead Sponsor
24 Previous Clinical Trials
15,172 Total Patients Enrolled
12 Trials studying Depression
7,027 Patients Enrolled for Depression
Paul Croarkin, MDPrincipal InvestigatorMayo Clinic
Karen HeartStudy DirectorNeuronetics