Synaptic Effects of iTBS for Depression in Adults
Official title: Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
Run by Mclean Hospital · NCT07593222 · Data updated 2026-11-12
Researchers are testing whether a brief form of brain stimulation, called iTBS, plus certain medicines, can better help adults with major depression who haven’t fully improved with standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | December 1, 2030 |
| Study ends | June 30, 2031 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07593222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with major depressive disorder who can safely receive TMS and study medications and have a stable regimen.
✕Probably not a fit
Individuals who do not respond to iTBS or cannot tolerate the study medications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study looks at how intermittent theta burst stimulation (iTBS) affects brain connections in people with major depressive disorder or in healthy participants. It uses sham iTBS, TMS, and pharmacologic agents like d-cycloserine and dextromethorphan to explore the role of NMDA receptors in the prefrontal cortex. The trial aims to understand whether combining brain stimulation with these drugs can produce stronger, more reliable antidepressant effects. Participants must be able to safely receive TMS and study medications and maintain stable treatment regimens. The study is conducted at McLean Hospital with collaboration from NIMH.
Why it matters
Potential benefit: If successful, the approach could lead to more effective iTBS-based treatments for depression.
How similar studies have gone: Prior research suggests iTBS has antidepressant potential, but efficacy varies and this study tests mechanisms in the dlPFC with pharmacologic augmentation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Can safely receive TMS and study drugs * Stable medication regimen for one month prior to study participation, and for the duration of the study * Not currently receiving TMS, ECT, or ketamine * No active safety concerns related to suicidality Exclusion Criteria: * History of seizures or epilepsy * History of intracranial pathology or lesions from any etiology * History of traumatic brain injury including prolonged loss of consciousness more than 15 min * Signs of increased intracranial pressure * Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.) * Major medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) * Severe migraines that may result in treatment intolerance. * Inability to tolerate MRI. * Pregnancy * Known allergic reaction to d-cycloserine or dextromenthorphan
Where it's running
-
McLean Hospital
Belmont, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Joshua C Brown, MD, PhD — Mclean Hospital
- Study coordinator: Joshua C Brown, MD, PhD
- Email: jbrown@mclean.harvard.edu
- Phone: 617-855-2944
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.