Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

A study testing NeuroStar TMS in people with Major Depressive Disorder, run by Neuronetics at 6 sites in United States.

Completed

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

Trial summary

The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: NeuroStar TMS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 6 sitesUnited States
Study dates: Aug 2011to Jul 2014
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥ 4.
Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode.
Capable and willing to provide informed consent.
Signed HIPAA authorization.
Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy.
If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.

Who cannot join

Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
Depression secondary to a general medical condition, or substance- induced;
Seasonal pattern of depression as defined by DSM-IV;
History of substance abuse or dependence within the past year except nicotine and caffeine);
Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;

Show all 24Show fewer

Bipolar disorder;
Eating disorder (current or within the past year);
Obsessive compulsive disorder (lifetime); or
Post-traumatic stress disorder (current or within the past year).
An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
Individuals with a clinically defined neurological disorder or insult including, but not limited to:
Any condition likely to be associated with increased intracranial pressure;
Space occupying brain lesion;
History of cerebrovascular accident;
Transient ischemic attack within two years;
Cerebral aneurysm;
Dementia;
Parkinson's disease;
Huntington's chorea;
Multiple sclerosis.
Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
History of treatment with Vagus Nerve Stimulation.
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Sheppard Pratt Health System
Baltimore, Maryland, 21285
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
Premier Psychiatric Group, L.L.C.
Lincoln, Nebraska, 68526
Center for Anxiety and Depression
Mercer Island, Washington, 98040
Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

Read the detailed description

This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.

Conditions: Major Depressive Disorder
Being tested: NeuroStar TMS
Keywords: TMS, Major Depressive Disorder, NeuroStar TMS
Medical subject headings: Depressive Disorder, Major

What participants receive

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

NeuroStar TMSDevice
NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.

Study groups in NCT01415154
Study group	Role	What they receive
Scheduled Treatment Arm	Active comparator	Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration. Receives: Device: NeuroStar TMS
Monthly Observational Follow up Arm	No intervention	Following completion of the efficacy assessments at Week 6, Office follow up every 4 week and NeuroStar TMS reintroduction as needed for clinical deterioration.

What is being measured

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

Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.
Measured: 12 month evaluation

Secondary outcomes (1)

Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.
Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.
Measured: 12 Month evaluation

Timeline

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

Aug 2011Jul 2014

First posted11 Aug 2011 (estimated)
Study startAug 2011
Primary completionSep 2013
Study completionJul 2014

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.
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: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01415154
Sponsor's protocol ID: 44-03001-000
Status last verified: Feb 2025
First submitted: 10 Aug 2011
Last updated: 4 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01415154
Acronym / sponsor ID: 44-03001-000
Conditions: Major Depressive Disorder
Keywords: TMS, Major Depressive Disorder, NeuroStar TMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: NeuroneticsUniversity, hospital or other
Study start: Aug 2011
Primary completion: Sep 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 4 Mar 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Scheduled Treatment Arm	Active comparator	Device: NeuroStar TMSFollowing completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration.
Monthly Observational Follow up Arm	No intervention	–Following completion of the efficacy assessments at Week 6, Office follow up every 4 week and NeuroStar TMS reintroduction as needed for clinical deterioration.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥ 4.
Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode.
Capable and willing to provide informed consent.
Signed HIPAA authorization.
Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy.

Key exclusion criteria (24 listed)

Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
Individuals with a clinically defined neurological disorder or insult including, but not limited to:
Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.

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
NeuroStar TMSNeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.	Device	Scheduled Treatment Arm

Primary outcome

Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
Time frame: 12 month evaluation
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.

1 secondary outcome

Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.
Time frame: 12 Month evaluation

Results and safety

Results posted to the registry on 4 Mar 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
Scheduled Treatment Arm	23	10
Monthly Observational Follow up Arm	26	6

Primary outcome: Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.

Time frame: 12 month evaluation. Count of participants. Unit: Participants

Measure	Scheduled Treatment Arm n = 23	Monthly Observational Follow up Arm n = 26
Value	5	4

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Scheduled Treatment Arm	0 of 23 (0%)	0 of 23 (0%)	Not reported
Monthly Observational Follow up Arm	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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.

David G. Brock, MD study director

Neuronetics

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

Questions about this trial

What is this clinical trial studying?

A study testing NeuroStar TMS in people with Major Depressive Disorder, run by Neuronetics at 6 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 6 inclusion and 24 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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 4 Mar 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?

Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase. (time frame: 12 month evaluation). 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 NCT01415154.

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 4 Mar 2025.