DepressionEarly Phase 1R33 MDDNCT07804459
Individualized fMRI-guided TMS for Depression
A Early Phase 1 study testing Active Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression and Major Depressive Disorder (MDD), run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
- What is being tested?
- Active Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Aug 2028
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, potential participants must meet all of the following eligibility criteria:
- 18-65 years old
- DSM-5 diagnosis of major depressive (at least 90%) or persistent depressive disorder (no more than 10%) as per SCID clinical interview.
- PHQ-9 score = or > than 10 (to maintain minimal severity of symptoms in the MDD sample)
- Comprehension of instructions in the English language.
- Capacity to provide informed consent and follow study procedures.
- Availability for the duration of the study.
Who cannot join
- Any individual who meets any of the following criteria at the time of enrollment will be excluded from participation:
- Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
- History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
- Current psychosis, mania, or substance use disorder
- Prior failed response to full rTMS or ECT/MST trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
- Inability to complete an MRI scan (e.g., claustrophobia, inability to remain still for extended periods).
Show all 26Show fewer
- Inability to tolerate TMS administration
- Significant handicaps that would interfere with testing procedures
- Acute systemic infection, high fever
- Acute sleep deprivation or medication/substance intoxication or withdrawal (TMS seizure risk)
- Current use of cyclosporine, tacrolimus, or others that can cause leukoencephalopathy.
- Pregnancy
- Dialysis
- Suicide attempt in past 6 months (safety precaution); similarly, if ideation is particularly pronounced, Drs. Oathes and Sheline will decide with the patient whether the benefit of participating in a sham controlled (all patients given the option to receive active treatment eventually) study outweighs the risks. If the patient has a mental health provider and acquiesces, consultation with the provider will also be instrumental in this decision.
- Current use of Bupropion (Wellbutrin) above 300 mg, benzodiazepines, lithium, monoamine oxidase inhibitors (MAOIs), and/or high doses of stimulant medication is exclusionary. Note: Exclusionary dosages or medications may be reduced or discontinued under the supervision of a medical provider. For detailed information please refer to section 5.3.1.
- Transportation limits or physical limits to attending daily M-F treatment sessions.
- Per study physician discretion medications likely to interfere with blood flow or otherwise compromise functional imaging measures.
- Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from procedure site; unlikely to be able to schedule daily treatment sessions, etc.)
- Study Participation Expectations
- During this study, participants will be asked to:
- Refrain from substance use (including marijuana and illicit drugs) for the duration of the study (self-attestation alone)
- Abstain from alcohol for 24 hours before study visits (self-attestation alone)
- Maintain a consistent level of caffeine consumption throughout the study period and avoid any significant increases (self-attestation).
- Not initiate, discontinue, or adjust any psychiatric medications or therapy treatments during the study period.
- Inform the study team of any new medical treatments or prescribed medications (e.g., antibiotics) to allow for safety review and determination of continued eligibility for the study.
- Participants who do not follow these considerations will be evaluated on a case-by-case basis. Principal Investigator will determine if study withdrawal is appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Lab Manager, 2157466751, almaris.figueroa-gonzalez@pennmedicine.upenn.edu
About this study
Official title: Engaging the Subgenual Cingulate With Brain Stimulation for Depression
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. The main questions it aims to answer are:
- Can brain responses in the sgACC before treatment predict improvement in depressive symptoms following TMS?
- Does a 6-week course of active TMS, compared with sham TMS, change brain responses in the sgACC?
- Are changes in sgACC responses during treatment associated with changes in depressive symptoms?
Read more
Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and depressive symptoms.
Participants will:
- Receive active or sham TMS every weekday for 6 weeks
- Undergo MRI scans with TMS before, during, and after the 6-week intervention to measure brain responses to stimulation
- Complete clinical assessments, questionnaires, and cognitive testing
- Complete follow-up assessments after the intervention
Read the detailed description
This double-blind, randomized, sham-controlled clinical trial will investigate engagement and modulation of brain circuitry involving the subgenual anterior cingulate cortex (sgACC) using individualized resting-state functional magnetic resonance imaging (fMRI)-guided transcranial magnetic stimulation (TMS) in adults with depression.
Following screening, participants will undergo a baseline MRI session that includes structural, diffusion, and resting-state imaging. Resting-state functional connectivity will be used to identify individualized cortical stimulation targets that are positively and negatively connected with the sgACC. Participants will also complete baseline clinical assessments, questionnaires, and cognitive testing.
Before the 6-week intervention, participants will undergo a TMS/fMRI session to measure sgACC responses to stimulation. Single-pulse TMS will be delivered to three sites: an individualized target positively connected with the sgACC, an individualized target negatively connected with the sgACC, and a vertex control site. TMS/fMRI data will also be collected before and after brief intermittent theta burst stimulation (iTBS) to the positively and negatively connected targets. These procedures will be used to evaluate whether sgACC responses before treatment are associated with subsequent improvement in depressive symptoms.
Participants will then be randomized in a 1:1 ratio to receive active or sham iTBS delivered to the individualized positively connected sgACC target every weekday for 6 weeks (30 sessions). Sham procedures will be designed to resemble active stimulation without delivering the intended therapeutic magnetic stimulation to the targeted brain circuit.
The TMS/fMRI procedures will be repeated after approximately 3 weeks of treatment and again following the 6-week intervention. Changes in TMS-evoked sgACC responses over the course of treatment will be evaluated in relation to changes in depressive symptoms and compared between the active and sham groups to assess modulation of the targeted brain circuit.
Clinical assessments and questionnaires will be conducted throughout the study to evaluate depressive symptoms and related clinical outcomes. The Montgomery-Åsberg Depression Rating Scale (MADRS) will serve as the primary measure of depression severity, and the Patient Health Questionnaire-9 (PHQ-9) will serve as a secondary measure. Participants will also complete the NIH Toolbox Cognition Battery before and after the 6-week intervention to assess cognitive functioning and explore relationships between cognitive performance, clinical outcomes, and neuroimaging measures.
Participants will complete remote follow-up assessments at 1, 6, and 12 months after completion of the blinded intervention. After the 1-month follow-up, participants assigned to sham who continue to have clinically significant depressive symptoms and meet study eligibility criteria may be offered an optional open-label active TMS intervention. Data from the open-label phase will be analyzed separately from the randomized sham-controlled phase.
- Conditions
- Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Persistent Depressive Disorder, PDD, MDD
- Being tested
- Active Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Transcranial Magnetic Stimulation (TMS)
- Keywords
- TMS, Transcranial Magnetic Stimulation, Brain Stimulation, Brain Imaging, Depression, fMRI, MDD, PDD, non-invasive brain stimulation, TMS treatment, TMS for depression, individualized treatment
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Repetitive Transcranial Magnetic Stimulation (rTMS)Device
The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) using MRI-guided neuronavigation.
Sham Transcranial Magnetic Stimulation (TMS)Device
The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Experimental | Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC). Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted cortical-sgACC circuit. Receives: Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham iTBS | Sham comparator | Participants will receive sham iTBS at the same individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) every weekday for 6 weeks (30 sessions). Receives: Device: Sham Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period.
MADRS is a clinician-rated measure of depressive symptom severity with total scores ranging from 0 to 60, where higher scores indicate greater depression severity. Change in MADRS total score will be calculated from baseline (pre-treatment) to post-treatment.
Measured: ~6 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention period follow up.
PHQ-9 is a patient-reported score that ranges from 0 to 27, where higher scores indicate greater depression severity. Change in PHQ-9 total score will be calculated from baseline (pre-treatment) to post-treatment.
Measured: ~6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive active or sham iTBS every weekday for 6 weeks (30 sessions). In both groups, stimulation will be delivered to an individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC). The active group will receive iTBS intended to stimulate the targeted cortical-sgACC circuit, while the sham group will undergo procedures of the same duration and appearance without the intended magnetic stimulation of the targeted circuit.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Desmond Oathes, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804459
- Sponsor's protocol ID
- 26-7480
- Other IDs
- 4R33MH135428-03
- Acronym
- R33 MDD
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging the Subgenual Cingulate With Brain Stimulation for Depression
- ClinicalTrials.gov ID
- NCT07804459
- Acronym / sponsor ID
- R33 MDD / 26-7480
- Conditions
- Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Persistent Depressive Disorder, PDD, MDD
- Keywords
- TMS, Transcranial Magnetic Stimulation, Brain Stimulation, Brain Imaging, Depression, fMRI, MDD, PDD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Sep 2026 (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.
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. The main questions it aims to answer are:
- Can brain responses in the sgACC before treatment predict improvement in depressive symptoms following TMS?
- Does a 6-week course of active TMS, compared with sham TMS, change brain responses in the sgACC?
- Are changes in sgACC responses during treatment associated with changes in depressive symptoms?
Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and depressive symptoms.
Participants will:
- Receive active or sham TMS every weekday for 6 weeks
- Undergo MRI scans with TMS before, during, and after the 6-week intervention to measure brain responses to stimulation
- Complete clinical assessments, questionnaires, and cognitive testing
- Complete follow-up assessments after the intervention
Detailed description
This double-blind, randomized, sham-controlled clinical trial will investigate engagement and modulation of brain circuitry involving the subgenual anterior cingulate cortex (sgACC) using individualized resting-state functional magnetic resonance imaging (fMRI)-guided transcranial magnetic stimulation (TMS) in adults with depression.
Following screening, participants will undergo a baseline MRI session that includes structural, diffusion, and resting-state imaging. Resting-state functional connectivity will be used to identify individualized cortical stimulation targets that are positively and negatively connected with the sgACC. Participants will also complete baseline clinical assessments, questionnaires, and cognitive testing.
Before the 6-week intervention, participants will undergo a TMS/fMRI session to measure sgACC responses to stimulation. Single-pulse TMS will be delivered to three sites: an individualized target positively connected with the sgACC, an individualized target negatively connected with the sgACC, and a vertex control site. TMS/fMRI data will also be collected before and after brief intermittent theta burst stimulation (iTBS) to the positively and negatively connected targets. These procedures will be used to evaluate whether sgACC responses before treatment are associated with subsequent improvement in depressive symptoms.
Participants will then be randomized in a 1:1 ratio to receive active or sham iTBS delivered to the individualized positively connected sgACC target every weekday for 6 weeks (30 sessions). Sham procedures will be designed to resemble active stimulation without delivering the intended therapeutic magnetic stimulation to the targeted brain circuit.
The TMS/fMRI procedures will be repeated after approximately 3 weeks of treatment and again following the 6-week intervention. Changes in TMS-evoked sgACC responses over the course of treatment will be evaluated in relation to changes in depressive symptoms and compared between the active and sham groups to assess modulation of the targeted brain circuit.
Clinical assessments and questionnaires will be conducted throughout the study to evaluate depressive symptoms and related clinical outcomes. The Montgomery-Åsberg Depression Rating Scale (MADRS) will serve as the primary measure of depression severity, and the Patient Health Questionnaire-9 (PHQ-9) will serve as a secondary measure. Participants will also complete the NIH Toolbox Cognition Battery before and after the 6-week intervention to assess cognitive functioning and explore relationships between cognitive performance, clinical outcomes, and neuroimaging measures.
Participants will complete remote follow-up assessments at 1, 6, and 12 months after completion of the blinded intervention. After the 1-month follow-up, participants assigned to sham who continue to have clinically significant depressive symptoms and meet study eligibility criteria may be offered an optional open-label active TMS intervention. Data from the open-label phase will be analyzed separately from the randomized sham-controlled phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive active or sham iTBS every weekday for 6 weeks (30 sessions). In both groups, stimulation will be delivered to an individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC). The active group will receive iTBS intended to stimulate the targeted cortical-sgACC circuit, while the sham group will undergo procedures of the same duration and appearance without the intended magnetic stimulation of the targeted circuit.
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Experimental | Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC). Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted cortical-sgACC circuit. |
| Sham iTBS | Sham comparator | Device: Sham Transcranial Magnetic Stimulation (TMS)Participants will receive sham iTBS at the same individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) every weekday for 6 weeks (30 sessions). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, potential participants must meet all of the following eligibility criteria:
- 18-65 years old
- DSM-5 diagnosis of major depressive (at least 90%) or persistent depressive disorder (no more than 10%) as per SCID clinical interview.
- PHQ-9 score = or > than 10 (to maintain minimal severity of symptoms in the MDD sample)
- Comprehension of instructions in the English language.
Key exclusion criteria (26 listed)
- Any individual who meets any of the following criteria at the time of enrollment will be excluded from participation:
- Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
- History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
- Current psychosis, mania, or substance use disorder
- Prior failed response to full rTMS or ECT/MST trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
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 |
|---|---|---|
| Active Repetitive Transcranial Magnetic Stimulation (rTMS)The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) using MRI-guided neuronavigation. | Device | Active iTBS |
| Sham Transcranial Magnetic Stimulation (TMS)The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region. | Device | Sham iTBS |
Primary outcome
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period.
Time frame: ~6 weeks
MADRS is a clinician-rated measure of depressive symptom severity with total scores ranging from 0 to 60, where higher scores indicate greater depression severity. Change in MADRS total score will be calculated from baseline (pre-treatment) to post-treatment.
Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention period follow up.
Time frame: ~6 weeks
PHQ-9 is a patient-reported score that ranges from 0 to 27, where higher scores indicate greater depression severity. Change in PHQ-9 total score will be calculated from baseline (pre-treatment) to post-treatment.
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 9 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression and Major Depressive Disorder (MDD), run by University of Pennsylvania 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 7 inclusion and 26 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 9 Sep 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.
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?
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 Almaris Figueroa Gonzalez (2157466751, almaris.figueroa-gonzalez@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period. (time frame: ~6 weeks). 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 9 Sep 2026.