Last reviewed · How we verify

NCT03240692: SAINT-TRD

Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort

Completed NA Results posted Last updated 21 April 2022
What this trial tests

NA trial testing Accelerated theta-burst stimulation treatment in Treatment Resistant Depression in 23 participants. Completed in 3 March 2020.

Timeline
1 May 2017
Primary endpoint
1 December 2019
3 March 2020

Quick facts

Lead sponsorStanford University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment23
Start date1 May 2017
Primary completion1 December 2019
Estimated completion3 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

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-month Primary · 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.

GroupValue95% 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
GroupValue95% CI
Accelerated Theta Burst Treatment-100± 0
4 weeks post-treatment
GroupValue95% 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
GroupValue95% CI
Accelerated Theta Burst Treatment-81.96± 25.98
Week 2
GroupValue95% CI
Accelerated Theta Burst Treatment-71.94± 37.96
Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment-65.54± 39.40
Week 6
GroupValue95% 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
GroupValue95% CI
Accelerated Theta Burst Treatment-81.12± 23.04
Week 2
GroupValue95% CI
Accelerated Theta Burst Treatment-74.58± 27.97
Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment-68.25± 32.54
Week 6
GroupValue95% CI
Accelerated Theta Burst Treatment-88.89± 0
Week 8
GroupValue95% 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
GroupValue95% CI
Accelerated Theta Burst Treatment-84.89± 15.36
Week 2
GroupValue95% CI
Accelerated Theta Burst Treatment-65.32± 49.57
Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment-54.84± 46.85
Week 6
GroupValue95% CI
Accelerated Theta Burst Treatment-90.74± 13.09
Week 8
GroupValue95% 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
GroupValue95% CI
Accelerated Theta Burst Treatment-85.06± 19.98
Week 2
GroupValue95% CI
Accelerated Theta Burst Treatment-78.17± 25.46
Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment-67.07± 37.74
Week 8
GroupValue95% CI
Accelerated Theta Burst Treatment-96.30± 5.24
Change From Baseline Functional Connectivity to Immediately Post-treatment Secondary · 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
GroupValue95% CI
Accelerated Theta Burst Treatment-2.335
sgACC-mDMN
GroupValue95% CI
Accelerated Theta Burst Treatment-3.027
sgACC-lDMN
GroupValue95% CI
Accelerated Theta Burst Treatment-2.106
sgACC-rDMN
GroupValue95% CI
Accelerated Theta Burst Treatment-2.660
A Neuropsychological Test Battery Testing Cognitive Abilities Secondary · 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
GroupValue95% CI
Accelerated Theta Burst Treatment48.81± 6.94
HVLT-DR_ immediately post-treatment
GroupValue95% CI
Accelerated Theta Burst Treatment48.18± 9.23
HVLT-DR_Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment49.77± 10.38
BVMT-DR_Pre-treatment
GroupValue95% CI
Accelerated Theta Burst Treatment51.06± 9.44
BVMT-DR_ immediately post-treatment
GroupValue95% CI
Accelerated Theta Burst Treatment54.35± 8.14
BVMT-DR_Week 4
GroupValue95% CI
Accelerated Theta Burst Treatment56.23± 11.02
DKEFS_Pre-treatment
GroupValue95% CI
Accelerated Theta Burst Treatment17.35± 4.20
DKEFS_ immediately post-treatment
GroupValue95% CI
Accelerated Theta Burst Treatment19.06± 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):

  1. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)
    Cole EJ, Stimpson KH, Bentzley BS, Gulser M, et al · · 2019 · cited 1× · DOI 10.1101/581280

Verify or expand the search:

Other recruiting trials for Treatment Resistant Depression

Currently open trials in the same condition.

Other Stanford University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing