Status:
NOT_YET_RECRUITING
Accelerated iTBS for Depression and Suicidality
Lead Sponsor:
University of Iowa
Conditions:
Major Depressive Disorder
Suicide
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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, n...
Eligibility Criteria
Inclusion
- • Ability to provide informed consent
- Availability for the duration of the study and willingness to comply with all study procedures
- Age 18 to 90
- Diagnosis of major depressive disorder by DSM-5 criteria
- Depressive symptoms are thought to be caused primarily by a major depressive episode and not by some other neurologic or psychiatric illness
- Failure of or intolerance to at least 2 antidepressant treatments of different therapeutic classes (can include psychotherapy trial or neurostimulation trial)
- Meets criteria for clinical eligibility for ECT treatment, including optimization of any medical conditions and completion of any medical testing or clearance as clinically indicated
- Able to consent voluntarily to treatment
- Score of at least 2 on the MADRS item 10
- Ability to sit or lie down for an extended period of time and willingness to adhere to the theta burst stimulation protocol
Exclusion
- • Presence of implanted ferromagnetic devices or materials, including cardiac pacemaker, cochlear implant, deep brain stimulation device, vagus nerve stimulation device, shrapnel, facial or scalp piercings that cannot be removed, or metallic face or head tattoos
- Pregnancy or lactation
- Previous bad reaction or intolerance to transcranial magnetic stimulation
- Febrile illness within 1 week
- Treatment with another investigational drug or other intervention within 30 days
- Recent substance abuse or use disorder within the past 6 months, excluding tobacco or infrequent cannabis use
- History of epilepsy or seizure disorder
- History of penetrating traumatic brain injury, multiple sclerosis, or history of brain surgery or intracranial hemorrhage
- Primary psychiatric or medical/neurologic illness other than MDD that is more likely to account for depressive symptoms, including severe personality disorder or psychotic illness
- Severe or moderate intellectual disability
- Major neurocognitive disorder
- Involuntary commitment or petition filed for involuntary ECT treatment
Key Trial Info
Start Date :
December 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04441008
Start Date
December 1 2026
End Date
July 1 2030
Last Update
May 20 2025
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