Trial · NCT07593222
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
NCT07593222, Phase 1, Phase 2, Recruiting, Mclean Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder. Trials, record NCT07593222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07593222
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
- NCT number
- NCT07593222
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Mclean Hospital
- Conditions
- Major Depression, Healthy Participants
- Interventions
- Sham iTBS, TMS, D-cycloserine, Dextromethophan, Placebo
- First posted
- 2026-05-18
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | P30 TMS-Evoked Potential (TEP) Amplitude | 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 | 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). |
| Secondary | Additional TEP Component Amplitudes | 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 | Change in amplitude of additional TEP peaks (N45, P60, and N100) measured before and after iTBS. P60 reflects mixed glutamatergic contributions, N45 reflects GABA-A receptor-mediated inhibitory tone, and N100 reflects GABA-B receptor-mediated inhibitory tone. These components are examined as exploratory markers of drug- and iTBS-induced changes in excitatory and inhibitory synaptic transmission in the dlPFC. |
| Secondary | 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16) | From enrollment to the end of treatment at 6 weeks | Self report measure of depressive symptoms. Score range: 0-27. Higher scores indicate more severe symptoms. |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | From enrollment to the end of treatment at 6 weeks | Self report measure of depressive symptoms. Score range: 0-27. Higher scores indicate more severe symptoms. |
| Secondary | 7-item Generalized Anxiety Disorder scale (GAD-7) | From enrollment to the end of treatment at 6 weeks | Self report measure of anxiety symptoms. Score range: 0-21. Higher scores indicate more severe symptoms. |
| Secondary | 24-item Behavior and Symptom Identification Scale (BASIS-24) | From enrollment to the end of treatment at 6 weeks | Self report measure of mental health and functional difficulties. Range: 0-96. Higher scores indicate more severe symptoms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07593222
GET https://conductscience.org/api/trials/v1/NCT07593222/registered