Major Depressive DisorderNCT02586688

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

A study testing Active NeuroStar® Transcranial Magnetic Stimulation (TMS) in people with Major Depressive Disorder, run by Neuronetics at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 13 sitesUnited States
Study dates: Oct 2015to Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.

Show all 19Show fewer

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).

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Sheppard Pratt Health System
Baltimore, Maryland, 21285
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
The Ohio State University
Columbus, Ohio, 43210
Dothan Behavioral Medicine
Dothan, Alabama, 36303
Florida Clinical Practice Association, Inc.
Gainesville, Florida, 32606
Rocky Mountain TMS
Grand Junction, Colorado, 81501
UCLA
Los Angeles, California, 90024
Integrative Psychiatry
Louisville, Kentucky, 40222
Stanford University
Palo Alto, California, 94305
Anchor Neuroscience
Pensacola, Florida, 32502
Mayo Clinic
Rochester, Minnesota, 55905
Beacon Medical Group
South Bend, Indiana, 46601

Other trials in United States

About this study

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

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).

Read the detailed 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.

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) .

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) .

Conditions: Major Depressive Disorder
Being tested: Active NeuroStar® Transcranial Magnetic Stimulation (TMS), Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Keywords: child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active NeuroStar® Transcranial Magnetic Stimulation (TMS)Device
Also called TMS, NeuroStar®
Compare active NeuroStar® coil with sham NeuroStar® coil.
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)Device
Also called TMS, NeuroStar®
Compare active NeuroStar® coil with sham NeuroStar® coil.

Study groups in NCT02586688
Study group	Role	What they receive
Phase I TMS Active	Active comparator	Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS) Receives: Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Phase I TMS Sham	Sham comparator	Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) Receives: Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2018

First posted26 Oct 2015 (estimated)
Study startOct 2015
Primary completionJan 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02586688
Sponsor's protocol ID: 44-02219-000
Status last verified: May 2025
First submitted: 23 Oct 2015
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PubMed 17573044
Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. doi: 10.1002/da.21969. Epub 2012 Jun 11.
PubMed 22689344
Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
PubMed 21951987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
ClinicalTrials.gov ID: NCT02586688
Acronym / sponsor ID: 44-02219-000
Conditions: Major Depressive Disorder
Keywords: child depression, depression, Transcranial Magnetic Stimulation, Adolescent Major Depressive Disorder, TMS, adolescent depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: NeuroneticsUniversity, hospital or other
Study start: Oct 2015
Primary completion: Jan 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 26 Oct 2015 (estimated)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

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) .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Phase I TMS Active	Active comparator	Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Phase I TMS Sham	Sham comparator	Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active NeuroStar® Transcranial Magnetic Stimulation (TMS)Also: TMS, NeuroStar®Compare active NeuroStar® coil with sham NeuroStar® coil.	Device	Phase I TMS Active
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)Also: TMS, NeuroStar®Compare active NeuroStar® coil with sham NeuroStar® coil.	Device	Phase I TMS Sham

Primary outcome

Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.
Time frame: 6 weeks
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TMS Active	54	48
TMS Sham	58	55

Primary outcome: Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.

Time frame: 6 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Phase I TMS Active n = 48	Phase I TMS Sham n = 55
Value	-11.1 (2.03)	-10.6 (2.00)

Population analysed: Open Label population not analyzed for primary treatment effect. Continued treatment for maintenance

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TMS Active Arm	3 of 54 (5.6%)	31 of 54 (57.4%)	0 of 54
TMS Sham Arm	1 of 58 (1.7%)	19 of 58 (32.8%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17573044O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
Results publication: PubMed 22689344Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. doi: 10.1002/da.21969. Epub 2012 Jun 11.
Results publication: PubMed 21951987Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Croarkin, MD principal investigator

Mayo Clinic

Karen Heart study director

Neuronetics

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active NeuroStar® Transcranial Magnetic Stimulation (TMS) in people with Major Depressive Disorder, run by Neuronetics at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586688, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.