Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
* Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
* Device: Open Label Active NeuroStar® TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features 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: 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): 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).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase I TMS Active<br>Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS) | Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)<br>* Compare active NeuroStar® coil with sham NeuroStar® coil.<br>* Other names: NeuroStar®;|
| Sham Comparator: Phase I TMS Sham<br>Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) | Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)<br>* Compare active NeuroStar® coil with sham NeuroStar® coil.<br>* Other names: NeuroStar®;|
| Other: Phase II Open Label Active TMS<br>Open label active TMS coil. Open label active NeuroStar® TMS. | Device: Open Label Active NeuroStar® TMS<br>* Open label NeuroStar® coil.<br>* Other names: NeuroStar®;|
| Other: Phase III Long-Term Follow up TMS Active<br>Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS. | Device: Open Label Active NeuroStar® TMS<br>* Open label NeuroStar® coil.<br>* Other names: NeuroStar®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression