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.
Percent Change in the Montgomery Asberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-monthPrimary· Pre-treatment and 1-month post treatment.
A ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Group
Value
95% CI
Accelerated Theta Burst Treatment
-67.07
± 34.71
Percent Change in the Columbia Suicide Severity Rating Scale (C-SSRS)Secondary· Pre-treatment to immediately post-treatment (on day 5) and 4 weeks post-treatment
A suicidal ideation rating scale created by researchers at Columbia University. The score was calculated by summing the answers to 5 questions. Score range - 0 to 5. Higher score indicate higher suicidal ideation.
Immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-100
± 0
4 weeks post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-100
± 0
Percent Change in the Hamilton Rating Scale for Depression (HAM-6)Secondary· Pre-treatment to immediately post-treatment (on day 5) and 2 weeks,4 weeks and 6 weeks post-treatment
A 6 item questionnaire used to score the severity of depression. Scale range - 0 to 22 with higher score indicative of greater depressive symptomology. Additional collection time points were pre-specified; only those time points for which data were collected are reported.
immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-81.96
± 25.98
Week 2
Group
Value
95% CI
Accelerated Theta Burst Treatment
-71.94
± 37.96
Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
-65.54
± 39.40
Week 6
Group
Value
95% CI
Accelerated Theta Burst Treatment
-87.5
± 0
Percent Change in the Hamilton Rating Scale for Depression (HAM-17)Secondary· Pre-treatment to immediately post-treatment (on day 5) and 2 weeks, 4 weeks, 6 weeks and 8 weeks post-treatment
A provider administered questionnaire used to assess remission and recovery from depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology. Additional collection time points were pre-specified; only those time points for which data were collected are reported.
immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-81.12
± 23.04
Week 2
Group
Value
95% CI
Accelerated Theta Burst Treatment
-74.58
± 27.97
Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
-68.25
± 32.54
Week 6
Group
Value
95% CI
Accelerated Theta Burst Treatment
-88.89
± 0
Week 8
Group
Value
95% CI
Accelerated Theta Burst Treatment
-93.52
± 4.1
Percent Change in the Beck Depression Inventory (BDI-II)Secondary· Pretreatment to immediately post-treatment (on day 5) and 2 weeks, 4 weeks, 6 weeks and 8 weeks post treatment.
A 21 item Self-report measure of depressive symptoms. Scale range - 0 to 63 with higher score indicative of greater depressive symptomology. Additional collection time points were pre-specified; only those time points for which data were collected are reported.
Immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-84.89
± 15.36
Week 2
Group
Value
95% CI
Accelerated Theta Burst Treatment
-65.32
± 49.57
Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
-54.84
± 46.85
Week 6
Group
Value
95% CI
Accelerated Theta Burst Treatment
-90.74
± 13.09
Week 8
Group
Value
95% CI
Accelerated Theta Burst Treatment
-100
± 0
Percent Change in the Montgomery Asberg Depression Rating Scale (MADRS)Secondary· Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks and 8 weeks post-treatment
A ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology. Additional collection time points were pre-specified; only those time points for which data were collected are reported.
immediately post treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
-85.06
± 19.98
Week 2
Group
Value
95% CI
Accelerated Theta Burst Treatment
-78.17
± 25.46
Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
-67.07
± 37.74
Week 8
Group
Value
95% CI
Accelerated Theta Burst Treatment
-96.30
± 5.24
Change From Baseline Functional Connectivity to Immediately Post-treatmentSecondary· Pre-treatment to immediately post treatment (on day 5).
Within subject changes in resting state functional connectivity of subgenual anterior cingulate cortex (sgACC) to default mode network (DMN). frontal (f)DMN (medial prefrontal cortex), median (m)DMN (posterior cingulate cortex and precuneus), left (l)DMN (left angular gyrus), right (r)DMN (right angular gyrus).
T-statistic (T-score): ratio of departure of estimated value from its hypothesized value to its standard error used in a t-test to determine whether to support or reject the null hypothesis. A T-score of ≥ 2.11 or ≤ -2.11 would be considered a statistically significant change if the ac
sgACC-fDMN
Group
Value
95% CI
Accelerated Theta Burst Treatment
-2.335
sgACC-mDMN
Group
Value
95% CI
Accelerated Theta Burst Treatment
-3.027
sgACC-lDMN
Group
Value
95% CI
Accelerated Theta Burst Treatment
-2.106
sgACC-rDMN
Group
Value
95% CI
Accelerated Theta Burst Treatment
-2.660
A Neuropsychological Test Battery Testing Cognitive AbilitiesSecondary· Pre-treatment, immediately post-treatment (on day 5) and 4 weeks post-treatment
The Hopkins Verbal Learning Test - Revised (HVLT-DR). Score range 0 to 72, higher score indicates better verbal learning. The Brief Visuospatial Memory Test - Revised (BVMT-DR). Score range 0 to 84, higher score indicates better visuospatial memory. Digit Span test and various tests from the Delis Kaplan Executive Function System (DKEFS) will be used to assess possible cognitive side-effects. Score range 0-36, higher score indicates better executive functions.
HVLT-DR_Pre-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
48.81
± 6.94
HVLT-DR_ immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
48.18
± 9.23
HVLT-DR_Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
49.77
± 10.38
BVMT-DR_Pre-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
51.06
± 9.44
BVMT-DR_ immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
54.35
± 8.14
BVMT-DR_Week 4
Group
Value
95% CI
Accelerated Theta Burst Treatment
56.23
± 11.02
DKEFS_Pre-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
17.35
± 4.20
DKEFS_ immediately post-treatment
Group
Value
95% CI
Accelerated Theta Burst Treatment
19.06
± 4.13
Sponsor's own description
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In this open label study, all participants will receive accelerated theta-burst stimulation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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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: 21 April 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/NCT03240692.