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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).
Full description
To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode (Phase I).
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) (Phase III).
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) (Phase II).
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Inclusion criteria
Exclusion criteria
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):
Primary purpose
Allocation
Interventional model
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100 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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