Accelerated iTBS for Depression and Suicidality

Sponsor
University of Iowa
Study ID
NCT04441008
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Accelerated Intermittent Theta Burst (aiTBS) — DEVICE
    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.
  • Electroconvulsive therapy (ECT) — DEVICE
    ECT as per standard clinical care and management.

Study Details

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.

Key Dates

First listed
Jun 22, 2020
Start date
Dec 31, 2026
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: aiTBS arm
    aiTBS treatment as lead-in phase to ECT standard of care treatment.
  • Active Comparator: ECT arm
    ECT as clinically indicated.

Primary Outcome Measure

Retention rate at completion of aiTBS vs the ECT group [ Time Frame: 5 days ]

Central Contacts

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