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Clinical Trial NCT07329153 for Treatment Resistant Depression (TRD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Neuronavigated aiTBS for TRD 247 Randomized Confirmatory Trial

Not yet recruiting
Clinical Trial NCT07329153 is an interventional study for Treatment Resistant Depression (TRD) and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2026 and continue until the study accrues 247 participants. Led by University of Texas Southwestern Medical Center, this study is expected to complete by 1 September 2031. The latest data from ClinicalTrials.gov was last updated on 9 January 2026.
Brief 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 ...Show More
Official Title

Neuronavigated and Non-Neuronavigated Accelerated Intermittent Theta-Burst Stimulation for Treatment-Resistant Depression A Sham-Controlled Randomized Controlled Trial

Conditions
Treatment Resistant Depression (TRD)
Other Study IDs
  • STU-2025-1926
NCT ID Number
Start Date (Actual)
2026-07
Last Update Posted
2026-01-09
Completion Date (Estimated)
2031-09
Enrollment (Estimated)
247
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
depression
TMS
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNeuronavigated aiTBS
TBS device placement during treatment determined by MRI imaging
aiTBS
Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation.
Active ComparatorNon-Neuronavigated aiTBS
Conventional device placement during treatment
aiTBS
Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation.
Sham ComparatorSham aiTBS
identical procedures as the other 2 groups but without turning on the device
aiTBS
Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
HDRS-17 - Depression severity assessment
depression severity as assessed by the Hamilton Depression Rating Scale-17 items (HDRS-17)
From Baseline visit until week 5 visit
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
From Baseline visit until week 5 visit.
Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
participant self-rated symptomatology
From Baseline visit until week 5 visit
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age: 18 to 65 years at the time of consent

  2. 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

  3. 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:

    1. Antidepressant medication at the maximum tolerated dose for at least 6 weeks, OR
    2. Evidence-based psychotherapy consisting of at least 12 sessions
  4. Depression Severity: Montgomery-Åsberg Depression Rating Scale (MADRS) score >19 at screening, indicating moderate to severe depression

  5. 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

  6. Informed Consent: Demonstrated capacity to provide written informed consent and comply with study procedures

  7. Availability: Ability to attend treatment sessions for 15 consecutive workdays (approximately 90 minutes per day) and complete assessments including 4-hour evaluations at baseline and endpoint

Psychiatric Exclusions:

  1. Any psychiatric disorder other than MDD and comorbid anxiety disorders, including but not limited to:

    (i) Bipolar disorder (Type I or II) (ii) Schizophrenia spectrum or other psychotic disorders (iii) Post-traumatic stress disorder (PTSD) (iv) Attention-deficit/hyperactivity disorder (ADHD) (v) Autism spectrum disorder (ASD) (vi) Obsessive-compulsive disorder (OCD) (vii) Current DSM-5 substance-use disorder (abuse or dependence) within the past 6 months, except nicotine dependence

  2. Personality disorder confirmed on clinical interview by an experienced study psychiatrist

  3. Severe suicidal ideation with structured plan (HDRS-17 item 3 score >2) or as determined by the evaluating psychiatrist

  4. Depressive symptoms better explained by another psychiatric condition, a medical condition, substance use, or use of medications

Medical and Neurological Exclusions:

  1. Any neurological disorder including but not limited to:

    (i) History of seizure disorder or epilepsy (ii) Family history of epilepsy (first-degree relatives) (iii) Significant head trauma with loss of consciousness >5 minutes (iv) Stroke or transient ischemic attack (v) Neurodegenerative disorders (e.g., Parkinson's disease, multiple sclerosis, dementia) (vi) Brain tumor or intracranial mass lesion

  2. 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

Contraindications to TMS/MRI:

  1. Presence of ferromagnetic material in or near the head, including:

    (i) Intracranial implants (e.g., aneurysm clips, shunts, stimulators) (ii) Cochlear implants or hearing aids (iii) Metallic facial tattoos or permanent makeup (iv) Other implanted medical devices deemed unsafe for MRI/TMS

  2. Inability to tolerate MRI scanning due to claustrophobia or other reasons

Medication Exclusions:

Current use of medications known to significantly alter cortical excitability:

  1. Anticonvulsants (including those used for mood stabilization)
  2. Psychostimulants
  3. Lithium
  4. Benzodiazepines exceeding 10mg diazepam-equivalent daily dose

Prior Treatment Exclusions:

  1. Electroconvulsive therapy (ECT) (≥ 6 sessions) in the current depressive episode
  2. Ketamine or esketamine treatment (≥ 6 sessions) in the current depressive episode
  3. Use of rTMS/iTBS (≥ 15 sessions) during the current depressive episode
  4. Vagus nerve stimulation (VNS) or deep brain stimulation (DBS) implantation

Psychotherapy:

• Concurrent evidence-based psychotherapy is permitted if initiated >4 weeks prior to enrollment and maintained at stable frequency throughout the tria

Other reasons:

  1. Unable to adhere to the study visit schedule
  2. Planning to relocate outside the study catchment area during the trial period
  3. No reliable transportation to attend study visits
  4. Current participation in another research study
  5. Current pregnancy (confirmed by in interview and clinical evaluation and, if deemed necessary, urine pregnancy test at screening)
  6. Currently breastfeeding
University of Texas Southwestern Medical Center logoUniversity of Texas Southwestern Medical Center
Study Responsible Party
Andre Russowsky Brunoni, Principal Investigator, Professor and Chief of the Division of Interventional Psychiatry, University of Texas Southwestern Medical Center
No contact data.
3 Study Locations in 1 Countries

California

University of California at San Diego (UCSD), San Diego, California, 92127, United States
UCSD Interventional Psychiatry, Contact, 858-207-0938, [email protected]
Greg Appelbaum, PhD, Principal Investigator

New York

Cornell University, New York, New York, 10065, United States
Interventional Psychiatry Program Weill Cornell Medicine, Contact, 646-962-2900, [email protected]
Conor Liston, MD PhD, Principal Investigator

Texas

University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
Clinical Research Coordinator, Contact, 214-645-2991, [email protected]
Andre Russowsky Brunoni, MD PhD, Principal Investigator