Treatment Resistant Depression (TRD)Phase 2NCT07287839
Parcel-guided rTMS for Major Depressive Disorder
A Phase 2 study testing Accelerated rTMS and Parcel-guided Accelerated rTMS in people with Treatment Resistant Depression (TRD), run by Soterix Medical.
Trial summary
Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Accelerated rTMS and Parcel-guided Accelerated rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Jun 2028
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
- At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
Who cannot join
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
- Anorexia nervosa or bulimia nervosa within the last year
- Unstable medical condition by history, physical exam or laboratory results
- Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- Contraindications to MRI (based on metal screening form)
- Meets criteria for claustrophobia
Show all 15Show fewer
- Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
- Neurological or neuromuscular disorder
- Requires medications for a general medical condition that contraindicate the TMS treatment
- Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
- History of ketamine treatment within 6 months
- History of monoamine oxidase inhibitor (MAOI) within the past month
- Lacks capacity to consent
- Taking medications that increase the risk of seizures.
- For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder
Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.
Read the detailed description
Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients with treatment resistant depression.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Accelerated rTMS, Parcel-guided Accelerated rTMS
- Keywords
- rTMS, TMS, parcel-guided, beam-F3
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated rTMSDevice
rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.
Parcel-guided Accelerated rTMSDevice
rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard rTMS | Active comparator | rTMS using standard targeting (Beam-F3) will be delivered Receives: Device: Accelerated rTMS |
| Parcel-guided rTMS | Experimental | rTMS will be delivered using brain-surface parcellation targeting Receives: Device: Parcel-guided Accelerated rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.
Measured: Baseline and at end of Week 1
Secondary outcomes (3)
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)
six-item subscale of psychiatric disorder severity where a score is given between 0 and 18 and a higher score indicates greater severity of symptoms
Measured: Baseline and at Week 1
Side-effect form (SEF)
Clinician-rated simple form to document the onset, course, severity, and causality of adverse events
Measured: Daily from Baseline until Week 1
Columbia suicide severity rating scale (C-SSRS)
Rating scale for suicidal ideation with scores ranging from 0 to 5 where a higher score indicates greater severity of symptoms
Measured: Baseline and Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant Depression (TRD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Abhishek Datta, PhD, Principal investigator, Soterix Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287839
- Sponsor's protocol ID
- RTMSP2
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8.
PubMed 32788580
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07287839
- Acronym / sponsor ID
- RTMSP2
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- rTMS, TMS, parcel-guided, beam-F3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 17 Dec 2025 (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.
Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.
Detailed description
Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients with treatment resistant depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rTMS | Active comparator | Device: Accelerated rTMSrTMS using standard targeting (Beam-F3) will be delivered |
| Parcel-guided rTMS | Experimental | Device: Parcel-guided Accelerated rTMSrTMS will be delivered using brain-surface parcellation targeting |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
- At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
Key exclusion criteria (15 listed)
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
- Anorexia nervosa or bulimia nervosa within the last year
- Unstable medical condition by history, physical exam or laboratory results
- Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- Contraindications to MRI (based on metal screening form)
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 |
|---|---|---|
| Accelerated rTMSrTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days. | Device | Standard rTMS |
| Parcel-guided Accelerated rTMSrTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days. | Device | Parcel-guided rTMS |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and at end of Week 1
Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.
3 secondary outcomes
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)
Time frame: Baseline and at Week 1
Side-effect form (SEF)
Time frame: Daily from Baseline until Week 1
Columbia suicide severity rating scale (C-SSRS)
Time frame: Baseline and Week 1
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 18 Dec 2025.
- Background: PubMed 32788580Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8.
- 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.
Abhishek Datta, PhD principal investigator
Soterix Medical, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accelerated rTMS and Parcel-guided Accelerated rTMS in people with Treatment Resistant Depression (TRD), run by Soterix Medical.
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 15 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: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yishai Valter, MS (888-990-8327, trials@soterixmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline and at end of Week 1). 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 NCT07287839, which also lists 1 linked publication.
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 18 Dec 2025.