Major Depressive EpisodeNCT04130958
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
A study testing Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) in people with Major Depressive Episode and Borderline Personality Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode, Borderline Personality Disorder, Suicide
- What is being tested?
- Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Diagnosed with BPD or MDE
- Chief complaint of suicidal thoughts and behaviors
Who cannot join
- Neurological conditions with known structural brain lesion
- Prior neurosurgical procedure
- Metal in the body that is ferromagnetic or metal injury to the eyes
- Epilepsy
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
- Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
Show all 9Show fewer
- Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report
- Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).
Read the detailed description
This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.
- Being tested
- Intermittent Theta Burst Transcranial Magnetic Stimulation (Active), Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)
- Keywords
- Transcranial Magnetic Stimulation, Intermittent Theta Burst
- Medical subject headings
- Borderline Personality Disorder, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)Device
Also called Active iTBS-TMS
iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.
Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)Device
Also called Sham iTBS-TMS
The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.
| Study group | Role | What they receive |
|---|---|---|
| MDE and Active iTBS-TMS | Experimental | This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS. Receives: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) |
| BPD and Active iTBS-TMS | Experimental | This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS. Receives: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) |
| MDE and Sham iTBS-TMS | Sham comparator | This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS. Receives: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham) |
| BPD and Sham iTBS-TMS | Sham comparator | This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS. Receives: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Functional Connectivity of Key Nodes
Measured using Magnetic Resonance Imaging
Measured: Through Treatment Completion, Average of 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Nov 2023
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 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, Principal investigator, 6177265348
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130958
- Sponsor's protocol ID
- 2019P002288
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
- ClinicalTrials.gov ID
- NCT04130958
- Acronym / sponsor ID
- 2019P002288
- Keywords
- Transcranial Magnetic Stimulation, Intermittent Theta Burst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 18 Oct 2019 (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 neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).
Detailed description
This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MDE and Active iTBS-TMS | Experimental | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS. |
| BPD and Active iTBS-TMS | Experimental | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS. |
| MDE and Sham iTBS-TMS | Sham comparator | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS. |
| BPD and Sham iTBS-TMS | Sham comparator | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age
- Diagnosed with BPD or MDE
- Chief complaint of suicidal thoughts and behaviors
Key exclusion criteria (9 listed)
- Neurological conditions with known structural brain lesion
- Prior neurosurgical procedure
- Metal in the body that is ferromagnetic or metal injury to the eyes
- Epilepsy
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
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 |
|---|---|---|
| Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)Also: Active iTBS-TMSiTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions. | Device | BPD and Active iTBS-TMS, MDE and Active iTBS-TMS |
| Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)Also: Sham iTBS-TMSThe sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents. | Device | BPD and Sham iTBS-TMS, MDE and Sham iTBS-TMS |
Primary outcome
Changes in Functional Connectivity of Key Nodes
Time frame: Through Treatment Completion, Average of 3 Days
Measured using Magnetic Resonance Imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Major Depressive Episode
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 3
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
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 principal investigator
6177265348
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) in people with Major Depressive Episode and Borderline Personality Disorder, 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 9 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 14 Jul 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Through Treatment Completion, Average of 3 Days). 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 14 Jul 2026.