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Treatment Resistant Depression / iTBS / rTMS · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered multicenter RCT comparing accelerated neuronavigated theta-burst stimulation (Stanford Neuromodulation Therapy protocol) delivered over 5 days against standard 10 Hz rTMS over 6 weeks, both at equal pulse dose (90,000), in 108 patients with treatment-resistant depression. No results are currently reported in this registry record; the trial is recruiting and outcome data are expected within 48 months of this registration.
Interventional, Randomized, Parallel, Single masking, Treatment purpose. Treatment Resistant Depression; age from 18 Years; to 99 Years. Intervention: intermittent theta burst transcranial magnetic stimulation…. Compared with: 10 Hz repetitive-transcranial-magnetic-stimulation (rTMS) — Active Comparator. n = 108. 4 sites: Netherlands.
Planned enrollment: 108 patients with treatment-resistant depression (no response to ≥2 evidence-based treatments) Primary outcome: Remission based on Hamilton depression rating scale assessed at 1 week post-treatment Intervention: 50 rTMS sessions using SNT protocol (iTBS, multiple sessions daily) delivered over 5 days with fMRI-guided neuronavigation to left DLPFC
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial directly addresses whether rapid neuronavigated theta-burst stimulation can improve remission rates in treatment-resistant depression compared to standard rTMS, with identical total pulse delivery. Results may inform treatment sequencing and resource allocation if the accelerated protocol proves superior. Clinicians should await published outcome data before integrating SNT protocols into practice.
This is a trial registration with no results reported; the study is actively recruiting and designed to test whether an accelerated neuronavigated protocol achieves superior remission to standard rTMS in treatment-resistant depression, but outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
This trial directly addresses whether rapid neuronavigated theta-burst stimulation can improve remission rates in treatment-resistant depression compared to standard rTMS, with identical total pulse delivery. Results may inform treatment sequencing and resource allocation if the accelerated protocol proves superior. Clinicians should await published outcome data before integrating SNT protocols into practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT05900271). This is a study registration, not published results. Lead sponsor: Amsterdam UMC, location VUmc. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 108 participants (ESTIMATED). Conditions: Treatment Resistant Depression. Interventions: DEVICE: rTMS; DEVICE: iTBS. Primary outcome measures: Remission , After 1 week.. Brief summary: INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression (TRD), whereas remission using a standard 10 Hz rTMS protocol is 25%. The improvement using the SNT protocol is achieved by combining 1) accelerated treatment with multiple sessions per day, 2) applying a higher overall pulse dose of stimulation, using intermittent Theta Burst Stimulation (iTBS), and 3) precise targeting of the region in the left dorsolateral prefrontal cortex (DLPFC), using functional MRI guided neuronavigation. OBJECTIVE To determine if the SNT protocol is more (cost-) effective compared to standard 10 Hz rTMS in patients with TRD, even though the number of pulses given in both protocols is equal, i.e., 90,000. STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks. STUDY POPULATION 108 Patients with TRD (no response to 2 or more evidence-based treatments). INTERVENTION 50 sessions using the SNT protocol in 5 days. The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI. COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard measurement procedures of the skull. OUTCOME MEASURES * Remission, based on the Hamilton depression rating scale * Cost effectiveness, based on healthcare resource use * Quality of life and positive mental health * Tolerability and safety * Relapse * Description of opportunities and difficulties with regard to implementation SAMPLE SIZE The investigators will enrol 108 patients (α=0.05, power is 0.80) including adjustment for attrition. COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare, reduced illness duration and absence from work. TIME SCHEDULE Within 36 months, the investigators will recruit and treat 108 patients with TRD: each center will recruit 9 patients per year. After the last follow-up assessments, the investigators will finalise the study within 12 months and report the results.
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