NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression
| NCT ID | NCT07560878 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mclean Hospital |
| Condition | Major Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2026-03-11 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Many people with depression do not get better with standard treatments like medication. One promising alternative is transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic pulses to stimulate specific brain regions. A particular pattern of TMS called continuous theta-burst stimulation (cTBS) is thought to reduce overactive brain activity in depression, but the investigators do not yet fully understand how it works at the level of brain cells and connections. This study aims to determine the biological mechanism by which cTBS changes brain activity in people with depression. Specifically, the investigators are testing two competing ideas: (1) that cTBS works by weakening the connections between brain cells through a process called long-term depression (LTD), which is driven by a chemical messenger system called glutamate; or (2) that cTBS works by increasing the brain's natural "braking" system, driven by a different chemical messenger called GABA. To test these ideas, participants with depression will receive cTBS along with one of four FDA-approved medications, or placebo, that either boost or block these chemical messenger systems. The investigators will measure changes in brain activity using electroencephalography (EEG) recorded simultaneously with TMS. Specific patterns in the EEG signal, called TMS-evoked potentials (TEPs), act as a window into how different brain cell types are responding to stimulation. Each participant will complete four study visits, each testing a different drug-TMS combination in random order. One group of participants will test drugs targeting the glutamate system (d-cycloserine and memantine). A second group will test drugs targeting the GABA system (lorazepam and baclofen). All drugs are given as a single oral dose and are commonly used in clinical practice. Understanding exactly how cTBS works at a biological level could open the door to more effective, personalized TMS treatments.
Eligibility 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 * Moderate to severe Major Depressive Disorder as indicated by the Patient Health Questionnaire or Quick Inventory of Depressive Symptomatology 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, baclofen, memantine, or lorazepam
Contact & Investigator
Joshua C Brown, MD, PhD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT07560878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07560878 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07560878 currently recruiting?
Yes, NCT07560878 is actively recruiting participants. Contact the research team at pganesh@mgb.org for enrollment information.
Where is the NCT07560878 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT07560878 clinical trial?
NCT07560878 is sponsored by Mclean Hospital. The principal investigator is Joshua C Brown, MD, PhD at Mclean Hospital. The trial plans to enroll 80 participants.
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