Neuronavigated aiTBS for TRD (NCT07329153) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuronavigated aiTBS for TRD
United States247 participantsStarted 2026-07
Plain-language summary
The purpose of this study is to confirm the efficacy of two recently introduced repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation - in treatment-resistant depression (TRD). Using a three-arm design (neuronavigated aiTBS, non-neuronavigated aiTBS, and sham), this randomized controlled trial (RCT) is the first to specifically investigate the incremental benefit of neuronavigation within an accelerated stimulation protocol, as well as the first confirmatory RCT comparing the efficacy of each of these active treatments vs. sham, overcoming previous generalizability issues and being conducted in an independent, multicenter US TRD sample.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18 to 65 years at the time of consent
. Diagnosis: Current major depressive episode (MDE) in the context of unipolar major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by clinical psychiatric interview
. Treatment Resistance: Documented failure to respond to at least two adequate antidepressant trials on the Antidepressant Treatment History Form-Short Form (ATHF-SF). An adequate trial is defined as:
. Antidepressant medication at the maximum tolerated dose for at least 6 weeks, OR
. Evidence-based psychotherapy consisting of at least 12 sessions
. Depression Severity: Montgomery-Åsberg Depression Rating Scale (MADRS) score \>19 at screening, indicating moderate to severe depression
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HDRS-17 - Depression severity assessment
Timeframe: From Baseline visit until week 5 visit
Trial details
NCT IDNCT07329153
SponsorUniversity of Texas Southwestern Medical Center
. Medication Stability: No changes in antidepressant medication type or dose for at least 6 weeks prior to randomization. Stable doses of permitted medications must be maintained throughout the trial
. Informed Consent: Demonstrated capacity to provide written informed consent and comply with study procedures
Exclusion criteria
. Any psychiatric disorder other than MDD and comorbid anxiety disorders, including but not limited to:
. Personality disorder confirmed on clinical interview by an experienced study psychiatrist
. Severe suicidal ideation with structured plan (HDRS-17 item 3 score \>2) or as determined by the evaluating psychiatrist
. Depressive symptoms better explained by another psychiatric condition, a medical condition, substance use, or use of medications
. Any neurological disorder including but not limited to:
. Unstable medical condition, defined as any condition requiring acute medical intervention or hospitalization within the past 3 months, or any condition that in the investigator's judgment could affect participant safety or study outcomes
. Presence of ferromagnetic material in or near the head, including:
. Inability to tolerate MRI scanning due to claustrophobia or other reasons