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 range18 Years – 65 Years

SexALL

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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
✓. 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

What they're measuring

HDRS-17 - Depression severity assessment

Timeframe: From Baseline visit until week 5 visit

Trial details

NCT IDNCT07329153

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

View on ClinicalTrials.gov More Treatment Resistant Depression (TRD) trials