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NCT07560878 · ClinicalTrials.gov registry record · Early Phase 1
Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression
A Early Phase 1 study, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
NCT07560878 is a Early Phase 1 study that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 80 participants.
The verdict
NCT07560878, a Early Phase 1 study, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Transcranial Magnetic Stimulation Sham
- DRUG Memantine
- DRUG D-Cycloserine (DCS)
- DEVICE Continuous theta-burst stimulation (cTBS)
- DRUG Lorazepam (drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-03-11 |
| Est. Completion | 2030-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07560878
The ClinicalTrials.gov registry entry for NCT07560878 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Transcranial Magnetic Stimulation Sham is the first listed.
NCT07560878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07560878 about?
NCT07560878 is a clinical study titled "Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression". 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-bu...
What is the current status of trial NCT07560878?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2026-03-11. Estimated completion is 2030-12.
What interventions are being tested in trial NCT07560878?
The interventions under investigation include: Transcranial Magnetic Stimulation Sham (DEVICE), Memantine (DRUG), D-Cycloserine (DCS) (DRUG), Continuous theta-burst stimulation (cTBS) (DEVICE), Lorazepam (drug) (DRUG).
Who is sponsoring clinical trial NCT07560878?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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