Adults 22 to 80, any sex, with Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.Primary· Pretreatment (baseline), 1-month post-treatment
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
Group
Value
95% CI
Active TBS-DLPFC
-53
± 35
Sham TBS-DLPFC
-11
± 29
Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17)Secondary· pre-treatment (baseline) to 1-month post-treatment
A provider administered questionnaire used to assess remission and recovery from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity.
Group
Value
95% CI
Active TBS-DLPFC
-52
± 29
Sham TBS-DLPFC
-12
± 27
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) ScoreSecondary· Pretreatment (baseline) to immediately post-treatment (day 8).
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment developed by multiple institutions including Columbia University. Participants were asked a series of 6 yes or no questions. Yes answers indicate more suicidal ideation. Here we report a count of participants with an increase, decrease or no change in suicidal ideation.
Increased
Group
Value
95% CI
Active TBS-DLPFC
0
Sham TBS-DLPFC
0
Decreased
Group
Value
95% CI
Active TBS-DLPFC
6
Sham TBS-DLPFC
1
No Change
Group
Value
95% CI
Active TBS-DLPFC
2
Sham TBS-DLPFC
5
Change in the Hamilton Rating Scale for Depression (HAM-6) ScoreSecondary· Baseline (pre-treatment) and at 1-month post-treatment
The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale.
The Ham-6 version consists of 6 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech). Each item is scored on a scale of 0 to 4, except for the somatic symptoms item, which is scored 0 to 2. On the HAM-6 there can be a total score of 22. Higher scores represent higher depression severity. Here, we report a count of participants with an overall increase, decrease or no change in total
Decreased
Group
Value
95% CI
Active TBS-DLPFC
8
Sham TBS-DLPFC
3
No Change
Group
Value
95% CI
Active TBS-DLPFC
2
Sham TBS-DLPFC
6
Increased
Group
Value
95% CI
Active TBS-DLPFC
1
Sham TBS-DLPFC
1
Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17)Secondary· Pre-treatment (baseline) to immediately post-treatment (day 8).
The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale.
The Ham-17 version consists of 17 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep and insight items which are scored 0 to 2. On the HAM-17 there can be a total score of 22. Higher scores represent higher depression severity.
Group
Value
95% CI
Active TBS-DLPFC
-59
± 31
Sham TBS-DLPFC
-20
± 22
Change From Baseline Functional Connectivity to Immediate Post-treatmentSecondary· Pretreatment (baseline) to immediately post-treatment (day 8).
We quantified the functional connectivity change between the subcallosal cingulate to the default mode network and within the default mode network using baseline and immediate post-treatment MRI scans. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from immediately post-treatment (day 8) to baseline.
lsgACC_lDMN
Group
Value
95% CI
Active TBS-DLPFC
0.071
± 0.242
Sham TBS-DLPFC
0.025
± 0.301
lDMN_rDMN
Group
Value
95% CI
Active TBS-DLPFC
-0.069
± 0.330
Sham TBS-DLPFC
0.117
± 0.565
Change From Baseline Functional Connectivity to 1-month Post-treatmentSecondary· Pretreatment (baseline) to 1-month post-treatment
We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from post-treatment(1m) to baseline.
lsgACC_lDMN
Group
Value
95% CI
Active TBS-DLPFC
0.090
± 0.287
Sham TBS-DLPFC
-0.163
± 0.258
lDMN_rDMN
Group
Value
95% CI
Active TBS-DLPFC
-0.039
± 0.702
Sham TBS-DLPFC
-0.056
± 0.388
Change in Baseline Heart Rate Variability to 1-month Post-treatmentSecondary· Pretreatment to 1-month post-treatment
Heart rate variability measures will be compared pre-treatment and 1-month post-treatment.
Group
Value
95% CI
Active TBS-DLPFC
46.609
± 25.262
Sham TBS-DLPFC
-26.670
± 36.464
Change in Baseline Heart Rate Variability to Immediate Post-treatmentSecondary· Pretreatment to immediate post-treatment (day 8).
Heart rate variability measures will be compared pre-treatment and immediately post-treatment.
Group
Value
95% CI
Active TBS-DLPFC
16.226
± 15.245
Sham TBS-DLPFC
-31.159
± 35.258
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05144789 — Personalized Therapeutic Neuromodulation for Anhedonic Depression
· NA
· completed
NCT04243798 — Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 18 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03068715.