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Study of Orbitofrontal Stimulation for Major Depressive Disorder

This study is investigating if a treatment called transcranial magnetic stimulation (TMS) to a specific brain area, the orbitofrontal cortex (OFC), can help improve symptoms of Major Depressive Disorder (MDD). TMS uses magnetic fields to change brain activity. Researchers want to see if active TMS, compared to a sham (placebo) TMS, reduces depression and rumination (repeated negative thoughts). You could be eligible if you are 18-65 years old, have a diagnosis of MDD with moderate to severe symptoms, and can speak English. The study will measure success by looking at changes in your depression and rumination scores using standard questionnaires. The current recruitment status is unclear.

Study design
This study is interventional and plans to enroll 80 participants. It includes a randomized, sham-controlled phase followed by an open-label phase where all participants receive active treatment.
What's involved
You will complete surveys at four timepoints: Day 1 (baseline) and Day 10 of the randomized phase, and Day 1 (baseline) and Day 10 of the open-label phase.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be assessed at baseline and on the last day of both the randomized and open-label phases.

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NCT07230990

Mechanisms Of Orbitofrontal Stimulation in Depression

Recruiting
NAAges 18–65InterventionalTreatment
Subha Subramanian
~80 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Sham TMSActive TMS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Beck Depression Inventory II (BDI-II)
Measured over The survey will be administered at 4 timepoints: Day 1 (baseline) and Day 10 (last day) of randomized phase; Day 1 (baseline) and Day 10 (last day) of open-label phase.
+2 more outcomes measured

Conditions

Major Depressive Disorder (MDD)

Explore related trials

Unipolar Depression

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Subha Subramanian, MD
[email protected]
6176675247
Email the study team

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Eligibility criteria

Inclusion

Age 18-65 years
Must be able to read, speak and understand English
DSM-5 diagnosis of major depressive disorder, experiencing a moderate to severe depressive episode (Hamilton Depression Rating Scale score greater than or equal to 17 points)
Must be judged by study staff to be capable of completing the study procedures
Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens

Exclusion

DSM-5 moderate to severe substance use disorder within the past three months, based on Structured Clinical Interview for DSM-5
Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
History of fainting spells of unknown or undetermined etiology that might constitute seizures
Diagnosis of epilepsy with the exception of a single seizure of benign etiology (e.g., febrile seizures) in the judgment of a board-certified neurologist
Current or past history of a neurological disorder, such as stroke, a progressive neurologic disease, or intracranial brain lesion(s); and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment
Any unstable medical condition
Any metal in the brain or skull (excluding dental fillings) unless cleared by the responsible covering MD
Any devices which could be affected by TMS or MRI such as a pacemaker, medication pump, nerve stimulator, cochlear implant, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
Pregnancy; All female participants will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study. The pregnancy test will be administered by study staff trained to administer point of care pregnancy testing that complies with institutional laboratory policies

What this trial measures

  • Beck Depression Inventory II (BDI-II)The survey will be administered at 4 timepoints: Day 1 (baseline) and Day 10 (last day) of randomized phase; Day 1 (baseline) and Day 10 (last day) of open-label phase.

    The BDI-II is a 21-item self-report questionnaire assessing the severity of depressive symptoms over the past two weeks. Each item is rated from 0 to 3, reflecting increasing symptom severity. The total score range is 0 to 63 points, where higher scores indicate worse depressive symptoms. The investigators will examine the change in BDI-II scores in each experimental phase (randomized and open-label).

  • Hamilton Depression Rating Scale (HDRS) - 24 item versionThe survey will be administered at 4 timepoints: Day 1 (baseline) and Day 10 (last day) of randomized phase; Day 1 (baseline) and Day 10 (last day) of open-label phase.

    The HDRS is a clinician-rated scale assessing the severity of depressive symptoms across mood, somatic, and cognitive domains. Items are scored on either 3- or 5-point scales depending on the symptom. The score ranges from 0 to 76, with higher scores reflecting greater severity.

  • Rumination Response Scale (RRS)The survey will be administered at 4 timepoints: Day 1 (baseline) and Day 10 (last day) of randomized phase; Day 1 (baseline) and Day 10 (last day) of open-label phase.

    The RRS is a 22-item self-report questionnaire measuring the tendency to engage in repetitive, negative thinking about one's distress or mood. Each item is rated from 1 ("almost never") to 4 ("almost always"). Scores range from 22 to 88 points, with higher scores indicating greater rumination.