NCT04441008

Accelerated iTBS for Depression and Suicidality

Radical aiTBS Protocol for Intractable Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this current study is to evaluate the feasibility, safety, and tolerability of "high dose" aiTBS in psychiatric inpatient and outpatients with treatment-refractory unipolar, non-psychotic major depressive disorder, using patients receiving ECT as an active comparator. Developing a better understanding of the feasibility and tolerability of adapting this treatment to an acutely ill patient population could lead to huge breakthroughs for clinician decision-making and for the further optimization of brain stimulation depression protocols. The results of this study can help guide future confirmatory efficacy trials of high-dose aiTBS by providing a better understanding of how feasibility, safety and tolerability compare to ECT, as well as unforeseen challenges of its use.

Conditions

• Major Depressive Disorder
• Suicide

Interventions

Type	Name	Description
DEVICE	Accelerated Intermittent Theta Burst (aiTBS)	High-dose intermittent theta burst administered at a treatment frequency 10x per day, with each treatment session duration 3x standard TMS (1800 pulses). Delivering 50 sessions in 5 days.
DEVICE	Electroconvulsive therapy (ECT)	ECT as per standard clinical care and management.

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-12-01
• Completion: 2030-07-01
• First posted: 2020-06-22
• Last updated: 2025-05-20

Regulatory

• FDA-regulated device study