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Understanding iTBS for Major Depression

This study is for people with Major Depression or healthy volunteers. It aims to understand how a brain stimulation treatment called intermittent theta burst stimulation (iTBS) works to help depression. iTBS uses magnetic pulses to stimulate the brain. Researchers are also testing if combining iTBS with D-cycloserine (a drug that helps strengthen brain cell connections) or Dextromethorphan (a drug that blocks these connections) changes how iTBS works. You might receive active iTBS, a sham (inactive) iTBS, or one of the study drugs or a placebo (inactive pill). The main goal is to measure changes in brain activity using a test called P30 TMS-Evoked Potential (TEP). You can join if you are 18 or older, can safely receive TMS and study drugs, and have stable medications. The study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study planning to enroll 100 participants, including those with Major Depression and healthy individuals. It involves different combinations of active iTBS, sham iTBS, D-cycloserine, Dextromethorphan, and placebo.
What's involved
You will have four study visits completed over a minimum of 3 to 6 weeks. You will receive iTBS or sham iTBS, and take an oral study drug or placebo about 2 hours before iTBS.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured from baseline to approximately 10 minutes after cTBS administration at each of the four study visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07593222

Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Mclean Hospital
~100 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Sham iTBSTMSD-cycloserineDextromethophanPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
P30 TMS-Evoked Potential (TEP) Amplitude
Measured over From baseline to approximately 10 minutes after cTBS administration, assessed at each of four study visits completed over a minimum of 3 to 6 weeks

Conditions

Major Depression
Healthy Participants

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Healthy ParticipantsUnipolar Depression

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Joshua C Brown, MD, PhD · PRINCIPAL_INVESTIGATOR · Mclean Hospital

Who to contact

Joshua C Brown, MD, PhD
[email protected]
617-855-2944
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • P30 TMS-Evoked Potential (TEP) AmplitudeFrom baseline to approximately 10 minutes after cTBS administration, assessed at each of four study visits completed over a minimum of 3 to 6 weeks

    Change in P30 peak amplitude measured by TMS-EEG before and after a single iTBS session. The P30 is a positive deflection occurring approximately 30 milliseconds after a TMS pulse, reflecting glutamatergic excitatory synaptic transmission. Change in P30 amplitude serves as an index of iTBS-induced LTP-like plasticity in the left dorsolateral prefrontal cortex. Comparisons will be made across drug conditions (placebo, d-cycloserine, dextromethorphan), between TMS conditions (active vs. sham), and between participant groups (MDD vs. healthy controls).