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NCT07593222 · ClinicalTrials.gov registry record · Phase 1
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
A Phase 1 study, sponsored by Mclean Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT07593222 is a Phase 1 study that has not yet begun recruiting, run by Mclean Hospital. The registered enrollment target is 100 participants.
The verdict
NCT07593222, a Phase 1 study, has not yet begun recruiting, sponsored by Mclean Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
Many people with depression do not get better with standard treatments like medications or talk therapy. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation treatment that uses magnetic pulses to stimulate areas of the brain involved in depression. One form of TMS called intermittent theta burst stimulation (iTBS) is FDA-cleared for depression and takes only 3 minutes to deliver. However, about one-third of patients do not respond to iTBS, and another one-third do not reach full remission. Improving iTBS requires a better understanding of how it works in the brain. iTBS is thought to work by strengthening connections between brain cells, a process called synaptic plasticity. This process depends on a type of brain receptor called the NMDA receptor. Most of what researchers know about how iTBS affects these connections comes from studies of healthy people. It is not known whether iTBS works the same way in the prefrontal cortex - the brain region targeted during depression treatment - or in people who actually have depression. This study has two phases. In Phase 1, both healthy volunteers and people with depression will complete 4 research visits to test how iTBS changes brain activity in the prefrontal cortex and whether medications that increase or decrease NMDA receptor activity change those effects. Each visit involves active or sham (inactive) iTBS combined with one of three study medications: a placebo (inactive pill), d-cycloserine (a medication that increases NMDA receptor activity), or dextromethorphan (a medication that decreases NMDA receptor activity). Brain activity is measured before and after each TMS session using electroencephalography (EEG), a painless test that records electrical signals from the scalp through a cap placed on the head. All participants also complete a brain MRI before beginning study visits for targeting purposes. In Phase 2, participants with depression will be offered a standard clinical course of 30 d
Interventions
- DRUG Placebo
- DEVICE TMS
- DEVICE Sham iTBS
- DRUG D-cycloserine
- DRUG Dextromethophan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07593222
The ClinicalTrials.gov registry entry for NCT07593222 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 100 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 Placebo is the first listed.
NCT07593222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07593222 about?
NCT07593222 is a clinical study titled "Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder". Many people with depression do not get better with standard treatments like medications or talk therapy. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation treatment that uses magnetic pulses to stimulate areas of the brain involved in depression. One form of TMS called inte...
What is the current status of trial NCT07593222?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-07-01. Estimated completion is 2031-06-30.
What interventions are being tested in trial NCT07593222?
The interventions under investigation include: Placebo (DRUG), TMS (DEVICE), Sham iTBS (DEVICE), D-cycloserine (DRUG), Dextromethophan (DRUG).
Who is sponsoring clinical trial NCT07593222?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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