Major Depressive DisorderNCT04278521
Mechanism of Action of Transcranial Magnetic Stimulation
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder, Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between the ages of 18-80
- DSM-IV diagnosis of Depressive Episode
- Patients requiring TMS treatment as part of their psychiatric care
Who cannot join
- Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Severe or unstable medical illness.
- MRI contraindications as determined by MGH department of radiology.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.
Read the detailed description
This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.
- Conditions
- Major Depressive Disorder, Depression
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation
- 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.
Transcranial Magnetic StimulationDevice
Also called TMS
Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar Depression | Other | Patients diagnosed with unipolar depression. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Functional Connectivity of Key Nodes in Depression
Measured by Magnetic Resonance Imaging
Measured: Through Treatment Completion, Average of 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startNov 2011
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan Camprodon, MD, PhD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278521
- Sponsor's protocol ID
- 2014P001835
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2020
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT04278521
- Acronym / sponsor ID
- 2014P001835
- Conditions
- Major Depressive Disorder, Depression
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.
Detailed description
This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unipolar Depression | Other | Device: Transcranial Magnetic StimulationPatients diagnosed with unipolar depression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females between the ages of 18-80
- DSM-IV diagnosis of Depressive Episode
- Patients requiring TMS treatment as part of their psychiatric care
Key exclusion criteria (4 listed)
- Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Severe or unstable medical illness.
- MRI contraindications as determined by MGH department of radiology.
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSTranscranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. | Device | Unipolar Depression |
Primary outcome
Changes in Functional Connectivity of Key Nodes in Depression
Time frame: Through Treatment Completion, Average of 6 Weeks
Measured by Magnetic Resonance Imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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.
Joan Camprodon, MD, PhD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder and Depression, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Functional Connectivity of Key Nodes in Depression (time frame: Through Treatment Completion, Average of 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.