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Major Depressive DisorderEarly Phase 1T5NCT06282146

Testing a Transdiagnostic TMS Treatment Target

A Early Phase 1 study testing transcranial magnetic stimulation in people with Major Depressive Disorder and Depression, run by Brigham and Women's Hospital at 1 site 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

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
transcranial magnetic stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
9 Sep 2024to 6 Jun 2026
Phase
Early Phase 1
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

  • Age 18-65
  • English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
  • Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode:
  • >20 on Beck Depression Inventory (BDI)
  • >20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15
  • Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17
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  • Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders):
  • Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD)
  • Obsessive compulsive disorder (OCD)
  • Post-traumatic stress disorder (PTSD)
  • Physician referral for individuals with either schizophrenia or schizoaffective disorder
  • Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit
  • Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
  • Agreement to lifestyle considerations
  • Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit)
  • Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment
  • Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and each TMS session

Who cannot join

  • Active pregnancy as determined by a urine pregnancy test
  • Positive urine drug screen for illicit substances (not including THC)
  • Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT)
  • Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
  • Receiving or planning to receive other TMS treatments during course of participation
  • History of
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  • Autism spectrum disorder
  • Neurosurgical intervention for depression
  • Intellectual disability
  • Severe cognitive impairment
  • Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion)
  • Untreated or insufficiently treated endocrine disorder
  • Treatment with investigational drug or intervention during the study period
  • Depth-adjusted TMS treatment dose > 65% maximum stimulator output
  • Existing tinnitus (ringing in the ears)
  • Current evidence of:
  • Mania or hypomania
  • Active suicidal ideation or a suicide attempt (defined by C-SSRS) within the past year
  • Neurological lesion
  • Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia > 4 hours per night with hypnotic, etc.).
  • Moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal (not including cannabis or nicotine use disorders)
  • Bipolar I disorder
  • For participants with schizophrenia or schizoaffective disorder referred by a physician:
  • Total PANSS score >90
  • Score >4 (moderate-severe) on any positive PANSS item
  • Active substance use disorder (other than nicotine)
  • Hospitalization for psychosis in the past 6 months
  • Severe borderline personality disorder
  • Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Read the detailed description

Psychiatric disorders are often studied individually. However, up to half of individuals who meet criteria for one psychiatric disorder also meet criteria for another. These individuals are difficult to diagnose and treat. Relative to those with one disorder, individuals with two or more have worse treatment outcomes, more functional impairment, and a greater risk of premature death.

Neuromodulation treatments like transcranial magnetic stimulation (TMS) work when routine psychotherapy and medications have not worked, but they typically target one disorder at a time. In fact, the TMS field is largely focused on strategies to make TMS more precise by targeting individual symptoms within a diagnosis. This strategy is important, but it may be difficult to scale and optimize in the setting of real-world psychiatric comorbidity. For example, there are 227 possible ways to meet criteria for major depressive disorder, complicating precision TMS strategies for individuals with or without comorbid disorders.

In this study, the investigators are moving in a different direction by targeting the brain network shared across psychiatric disorders in treatment-seeking individuals with more than one psychiatric disorder. This approach is based upon prior work. In a 2023 Nature Human Behavior study, the investigators analyzed four independent datasets with coordinate and lesion network mapping to test for a brain network shared across psychiatric disorders. They found that atrophy coordinates across six psychiatric disorders (193 studies) mapped to a common brain network defined by positive connectivity to the anterior cingulate and insula, and by negative connectivity to posterior parietal and lateral occipital cortices. The investigators verified that this transdiagnostic network was robust to leave-one-diagnosis-out cross validation and specific to atrophy coordinates from psychiatric versus neurodegenerative disorders (72 studies). Lesion-induced damage to this network correlated with the number of post-lesion psychiatric diagnoses in an independent dataset (194 patients). The transdiagnostic network also aligned with neurosurgical ablation targets for psychiatric disorders (4 targets), suggesting possible therapeutic relevance and generating testable hypotheses for neuromodulation. Importantly, the candidate TMS target that emerges from this transdiagnostic network is also a critical node of the convergent depression network that was derived across 14 independent datasets. This target has not been robustly tested for major depressive disorder (MDD) or transdiagnostic symptoms.

In this open-label pilot trial, the investigators will test the hypothesis that modulating the transdiagnostic network with transcranial magnetic stimulation (TMS) will be safe and tolerable. Secondary outcomes will assess changes in the cumulative burden of psychopathology in individuals with MDD plus at least one additional psychiatric disorder. This approach is novel in three important ways: 1) This study will enroll, not exclude, individuals with multiple psychiatric illnesses. Most clinical trials selectively enroll individuals with a single diagnosis, a strategy that does not generalize to real-world settings where psychiatric comorbidity is common and difficult to treat. 2) The transdiagnostic target was validated with causal sources of information (i.e., brain lesions, neurosurgical ablation). In other words, this study will optimize the "where to stimulate" factor. TMS targets are usually derived from functional neuroimaging studies that identify correlates of illness. These correlates could cause, compensate for, or be epiphenomena of treatment or other variables, an interpretation that matters for TMS. 3) The investigators will use the most rapid-acting and robust TMS protocol. In other words, they will optimize the "how to stimulate" factor. Conventional TMS protocols require scalp-targeted treatments delivered weekdays for 6-8 weeks. By contrast, the accelerated intermittent theta burst (iTBS) protocol in this study is adapted from Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), which consists of MRI-guided treatment delivered 10 times a day for 5 days.

Being tested
transcranial magnetic stimulation
Medical subject headings
Depressive Disorder, Major, Depression, Mental Disorders, Mood Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

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

  • transcranial magnetic stimulationProcedure or surgery

    Also called TMS, accelerated intermittent theta burst stimulation, aiTBS

    non-invasive form of brain stimulation

Study groups in NCT06282146
Study groupRoleWhat they receive
Open-label aiTBS to posterior parietal cortexExperimental10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target.
Receives: Procedure: transcranial magnetic stimulation

What is being measured

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

  1. Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire

    Questionnaire asking about the incidence, frequency, and severity of common TMS-related side effects such as headache, tinnitus, and neck pain.

    Higher severity and frequency of side effects indicates lower tolerability

    Measured: Each morning before treatment and afternoon after treatment during the 5 days of treatment

  2. Feasibility as measured by number of the 50 treatments completed

    0-50 treatments more treatments completed: higher feasibility

    Measured: Throughout the 5 days of treatment

Secondary outcomes (3)
  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Depression severity rating scale (0-60, higher numbers indicate higher severity)

    Measured: Before treatment and two weeks after treatment ends

  2. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC)

    Transdiagnostic rating scale (each question rated 0-4) Minimum score: 0 Maximum score: 92 Higher score indicates worse outcome or worse overall psychiatric burden

    Measured: Before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

  3. World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

    36-item functional assessment (each question rated 1-5) Minimum: 36 Maximum: 180 Can also be scored by percentiles Higher score indicates more disability

    Measured: Before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

Timeline

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

  1. First posted28 Feb 2024
  2. Study start9 Sep 2024
  3. Primary completion23 May 2025
  4. Study completion6 Jun 2026

Resources

More details

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

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282146
Sponsor's protocol ID
2024P000252
Acronym
T5
Status last verified
Jun 2025
First submitted
6 Feb 2024
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing transcranial magnetic stimulation in people with Major Depressive Disorder and Depression, run by Brigham and Women's 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 17 inclusion and 29 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 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire (time frame: Each morning before treatment and afternoon after treatment during the 5 days of treatment). The study lists 2 primary outcomes in all. 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 13 Jul 2026.

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Testing a Transdiagnostic TMS Treatment Target | AzTrials