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NCT Number: NCT04441008

Accelerated iTBS for Depression and Suicidality

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Depressive Disorder Depressive Disorder, Major Epilepsies, Partial Epilepsy Epilepsy, Rolandic Epileptic Syndromes Mental Disorders Mood Disorders Nervous System Diseases Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• 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 criteria

• 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

Treatment and study plan

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.

Other names: SAINT Protocol, accelerated TMS

Electroconvulsive Therapy (ECT)

Device

ECT as per standard clinical care and management.

Primary outcomes

Retention rate at completion of aiTBS vs the ECT group

Time frame: 5 days

The primary tolerability endpoint is the proportion of aiTBS or ECT patients completing the protocol to a degree thought to be satisfactory for achieving the intended antidepressant effect. Completion for aiTBS arm is defined as completion of at least 60% of the treatment protocol (30 of 50 treatments) with treatments on at least 60% of days (3 of 5 days during the week). Completion for ECT arm is defined as completion of at least 2 of 3 ECT treatments during the first week.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Pace, MS

CONTACT

[email protected]

(319) 384-9302

Nicholas Trapp, MD

CONTACT

[email protected]

(319) 467-8188

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Radical aiTBS Protocol for Intractable Depression

Acronym: RAPID

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2030
First posted: Jun 22, 2020
Registry last updated: May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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