FDA-cleared accelerated Deep TMS protocol for major depression
Service Overview
In September 2025, the FDA expanded clearance for BrainsWay Deep TMS to include an accelerated protocol for adults with major depressive disorder (MDD), including patients with comorbid anxiety symptoms. Because our clinic uses BrainsWay Deep TMS systems, we can review whether this shorter schedule fits your clinical history, goals, and logistics.
Like standard Deep TMS, accelerated Deep TMS is non-invasive and does not require anesthesia or downtime. The main difference is timing: several shorter sessions are grouped together so the acute phase can be completed in fewer treatment days.
In the multisite randomized controlled trial summarized by BrainsWay, the accelerated protocol produced outcomes comparable to the standard protocol while requiring considerably fewer visits to the clinic.
Cleared Protocol
The FDA clearance was based on a structured schedule that combines an intensive acute phase with weekly follow-up visits.
Important: The final schedule is always individualized. FDA clearance defines the protocol, but real-world availability still depends on clinical history, safety, and insurance logistics.
Study Findings
The expanded clearance was supported by a multicenter, randomized, blinded, controlled non-inferiority trial evaluating accelerated Deep TMS with iTBS for depression.
After statistical adjustment, HDRS-21 scores decreased by 19.02 points in the accelerated group and 19.79 points in the standard group. Response rates were 87.8% and 87.5%, respectively, while remission rates were 78.0% and 87.5%.
Median time to remission was 21 days in the accelerated group versus 28 days in the standard group, and no severe adverse events were reported.
19.02
HDRS-21 points
Adjusted score reduction reported in the accelerated arm.
87.8%
response rate
Clinical response reported for the accelerated protocol.
78.0%
remission rate
Remission reached in the accelerated study arm.
21 days
median time to remission
Compared with 28 days in the standard treatment arm.
Getting Started
We keep the first steps clear so you know what happens before treatment begins.
Planning Considerations
Accelerated Deep TMS expands treatment options, but it does not mean every patient should use the intensive schedule.
Candidacy: It may be worth discussing if you are an adult with MDD, have not improved enough with antidepressants, and want a shorter acute treatment window.
Coverage: Because accelerated scheduling is a newer option, coverage can vary by plan. We review prior authorization, session limits, and benefits before confirming a schedule.
Alternatives: For some patients, standard Deep TMS or esketamine / Spravato may remain the more practical option depending on symptoms, time demands, and insurance benefits.
If you want broader context, you can also review our TMS for Depression page or learn more about esketamine / Spravato.
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