Evidence map›Paper›PMID 39154984›Full record

Trial reportJournal of affective disorders2024

Fast depressive symptoms improvement in bipolar I disorder after Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT): A two-site feasibility and safety open-label trial.

Kevin Li, Amy Bichlmeier, Caitlin DuPont, Jennifer E Siegel-Ramsay, Alexa Comfort, Erin Logue, Katy H Stimpson, Brandon Bentzley, Nolan Williams, Irving Reti and 2 more

Abstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of affective disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
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  5. Review
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  9. Review
  10. Article
  11. Review
  12. Bipolar disorder.Lancet (London, England) · 2025
    Review
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kevin LiDepartment of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kevinli@jhmi.edu.
Amy BichlmeierDepartment of Psychiatry and Behavioral Sciences, University of Texas at Austin Dell Medical School, Austin, TX, USA.
Caitlin DuPontDepartment of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jennifer E Siegel-RamsayDepartment of Psychiatry and Behavioral Sciences, University of Texas at Austin Dell Medical School, Austin, TX, USA.
Alexa ComfortDepartment of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Erin LogueDepartment of Psychiatry and Behavioral Sciences, University of Texas at Austin Dell Medical School, Austin, TX, USA.
Katy H StimpsonMagnus Medical, Burlingame, CA, USA.
Brandon BentzleyMagnus Medical, Burlingame, CA, USA.
Nolan WilliamsDepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
Irving RetiDepartment of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jorge AlmeidaDepartment of Psychiatry and Behavioral Sciences, University of Texas at Austin Dell Medical School, Austin, TX, USA.
Peter ZandiDepartment of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Funding

Neurochemical & Behavioral Correlates of ETOH EffectsT32AA007471 · NIAAA · UNIVERSITY OF TEXAS AUSTIN · PI Kimberly Nixon · 1987 to 2026
$9.2M
Neurodevelopmental Patterns of Social Reactivity in Youth at Increased Familial Risk for Bipolar I DisorderF32MH135706 · NIMH · UNIVERSITY OF TEXAS AT AUSTIN · PI SIEGEL-RAMSAY, JENNIFER E · 2024 to 2025
$173k
NIAAA NIH HHS T32 AA007471NIMH NIH HHS F32 MH135706
6 · The paper itself

Abstract

backgroundAlthough there are a few first-line treatment options for bipolar depression, none are rapid-acting. A new rTMS protocol, Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), has been shown to have a rapid antidepressant effect in major depressive disorder (MDD). We examined the preliminary safety, tolerability, and efficacy of SAINT for the treatment of depression in a small sample of persons with treatment-resistant bipolar I disorder.

methodsParticipants with treatment-resistant bipolar I disorder currently experiencing moderate to severe depression were treated with open-label SAINT. Resting-state functional MRI (fMRI) was used to generate individualized treatment targets for each participant based on the region of the left dorsolateral prefrontal cortex most anticorrelated with the subgenual anterior cingulate cortex. Participants were treated with 10 iTBS sessions daily, with 50-min intersession intervals, for up to 5 consecutive days. The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to immediate follow-up after treatment.

resultsWe treated 10 participants and found a mean reduction of 16.9 in MADRS scores, with a 50 % response rate and 40 % remission rate immediately following treatment. 60 % of participants met remission criteria within the 1-month period following treatment. No serious adverse events, manic episodes, or cognitive side effects were observed. LIMITATIONS: Our study has a limited sample size and larger samples are needed to confirm safety and efficacy.

conclusionsSAINT has shown preliminary feasibility, safety, tolerability, and efficacy in treating treatment-resistant bipolar I depression. Double-blinded sham-controlled trials with larger samples are needed to confirm safety and efficacy.

Indexed as

Bipolar DisorderFeasibility StudiesMagnetic Resonance ImagingTranscranial Magnetic StimulationAdultDepressionDepressive Disorder, Treatment-ResistantDorsolateral Prefrontal CortexFemaleGyrus CinguliHumansMaleMiddle AgedPsychiatric Status Rating ScalesTreatment OutcomeAccelerated iTBSBipolarDepressionSAINTSNTTMS

Identifiers

PMID39154984
PMCPMC11495146

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.