Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02586688 |
Recruitment Status : Unknown
Verified January 2018 by Neuronetics.
Recruitment status was: Active, not recruiting
First Posted : October 26, 2015
Last Update Posted : February 5, 2018
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS) Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) Device: Open Label Active NeuroStar® TMS | Not Applicable |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Phase I TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
|
Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
|
Sham Comparator: Phase I TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
|
Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
|
Phase II Open Label Active TMS
Open label active TMS coil. Open label active NeuroStar® TMS.
|
Device: Open Label Active NeuroStar® TMS
Open label NeuroStar® coil.
Other Names:
|
Phase III Long-Term Follow up TMS Active
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
|
Device: Open Label Active NeuroStar® TMS
Open label NeuroStar® coil.
Other Names:
|
- Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value. [ Time Frame: 6 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586688
United States, Alabama | |
Dothan Behavioral Medicine | |
Dothan, Alabama, United States, 36303 | |
United States, California | |
UCLA | |
Los Angeles, California, United States, 90024 | |
Stanford University | |
Palo Alto, California, United States, 94305 | |
United States, Colorado | |
Rocky Mountain TMS | |
Grand Junction, Colorado, United States, 81501 | |
United States, Florida | |
Florida Clinical Practice Association, Inc. | |
Gainesville, Florida, United States, 32606 | |
Anchor Neuroscience | |
Pensacola, Florida, United States, 32502 | |
United States, Indiana | |
Beacon Medical Group | |
South Bend, Indiana, United States, 46601 | |
United States, Kentucky | |
Integrative Psychiatry | |
Louisville, Kentucky, United States, 40222 | |
United States, Maryland | |
Sheppard Pratt Health System | |
Baltimore, Maryland, United States, 21285 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Ohio | |
University of Cincinnati College of Medicine | |
Cincinnati, Ohio, United States, 45219 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Paul Croarkin, MD | Mayo Clinic | |
Study Director: | Karen Heart | Neuronetics |
Responsible Party: | Neuronetics |
ClinicalTrials.gov Identifier: | NCT02586688 |
Other Study ID Numbers: |
44-02219-000 |
First Posted: | October 26, 2015 Key Record Dates |
Last Update Posted: | February 5, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
child depression depression Transcranial Magnetic Stimulation |
Adolescent Major Depressive Disorder TMS adolescent depression |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |