Neuronavigated aiTBS for TRD
ConditionTreatment Resistant Depression (TRD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Antidepressant medication at the maximum tolerated dose for at least 6 weeks, OR
Evidence-based psychotherapy consisting of at least 12 sessions
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- aiTBS
Treatment groups
247 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
University of California, San Diego
Collaborator
Cornell University
Collaborator
Source ClinicalTrials.gov