True · Brier 0.01

A randomized controlled trial of SNT or another accelerated iTBS protocol for depression, reported after 11 July 2022, meets its prespecified primary endpoint with statistical significance.

TRUE on the date of the first sponsor topline release, ClinicalTrials.gov results posting or peer-reviewed publication dated after 2022-07-11 that reports a randomized controlled trial of SNT (Stanford Neuromodulation Therapy, the accelerated intermittent theta-burst TMS protocol commercialized by Magnus Medical) or another accelerated iTBS protocol for a depressive disorder, distinct from the Stanford SNT trial already published at the statement date, in which the prespecified primary efficacy endpoint met statistical significance versus the control arm as reported by the sponsor or the authors. Open-label series, secondary endpoints and pooled analyses do not count. Resolution source: the trial's ClinicalTrials.gov record and results posting, with the first peer-reviewed publication or sponsor release fixing the date. FALSE at the deadline when no such trial result has been reported.

Resolution source: ClinicalTrials.gov record and results posting of the trial; peer-reviewed publication or sponsor release as the secondary source

Readings: 'SNT and similar approaches' is read as SNT or another accelerated iTBS protocol (several iTBS sessions a day over about five days), per the author's own description of SNT in the post.; 'demonstrate statistical significance' is read as the primary efficacy endpoint meeting significance in a randomized controlled trial; the author names randomized controlled trials as the test in the same post (owen-0072).; 'and be Helpful' is split off as owen-0070-b and is not written into this event.

escalated (criterion): PubMed shows no qualifying multi-daily theta-burst RCT in depression from 2022-07-12 to 2024-07-10: Wilkening 2022 and Li 2023 missed their primary endpoints; Kong 2023 was a non-inferiority trial of V1 versus DLPFC with no sham arm; Huang 2024, Zhang 2024 and Mallik 2022 were not significant. So Sheline et al. (JAMA Psychiatry online 2024-07-10; 10 sessions a day for 5 days; MADRS -14.75 versus sham, P<.001) is the first positive RCT, but its population is treatment-refractory bipolar depression. The criterion says "a depressive disorder"; DSM-5 files bipolar disorders in a separate chapter, while the proposition says "for depression" and the registered conditions include treatment-resistant depression. If bipolar depression is excluded, the next candidate is Ramos et al. (online 2025-03-05; TRD; 3 sessions a day for 15 weekdays), outside the "about five days" reading. The readings differ by eight months; the criterion does not settle it.