Recruiting

Accelerated Intermittent Theta Burst

Sponsor:

University of Texas at Austin

Code:

NCT06523439

Conditions

Major Depressive Disorder

Depression in Adolescence

Depression

Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Not accepted

Interventions

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

Study Details

Brief summary:

This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS)-is effective as a first-line therapy in treating adolescents aged 13-20 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.

The main questions this trial aims to answer are:

  • Does aiTBS relieve symptoms of depression as a first-line therapy in adolescents?
  • Is aiTBS a feasible option as a first-line treatment for adolescent depression?

Researchers will measure the depression symptoms in adolescent participants before and after aiTBS. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.

Adolescent participants will:

  • Remain antidepressant-free throughout the study period of 6-7 weeks.
  • Receive an fMRI of their head for precision targeting
  • Receive 5 days of aiTBS

Conditions

Major Depressive Disorder

Depression in Adolescence

Depression

Major Depressive Episode

Study ID

NCT06523439

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or Female, between the ages of 13 and 20 at the time of screening.
2. Able to read, understand, and provide written, dated assent and/or consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
3. Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
4. No prior major depressive episodes (MDEs) as determined by MINI-KID
5. CDRS-R score of ≥40 at screening (Visit 1).
6. Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 12 weeks of antidepressant medication in the past 2 years and fewer than 10 psychotherapy sessions for depression in the past year; willingness to taper medications and stop psychotherapy if recently started and within the window defined above.)
7. TMS naive.
8. Access to ongoing psychiatric care before and after completion of the study.
9. In good general health, as evidenced by medical history.
10. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

1. Pregnancy
2. High-risk for suicide or active suicidal ideation as determined by clinical interview
3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (>4 on SAPAS; >16 on GAD-7)
4. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
5. Current mania or psychosis
6. Bipolar Affective Disorder and/or primary psychotic disorders.
7. Autism Spectrum disorder or Intellectual Disability
8. A diagnosis of obsessive-compulsive disorder (OCD)
9. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
10. Urine screening test positive for illicit substances.
11. Any history of ECT (greater than 8 sessions) without meeting responder criteria
12. Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
13. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
14. Untreated or insufficiently treated endocrine disorder.
15. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
16. Contraindications to MRI (ferromagnetic metal in their body).
17. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
18. Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)
19. Treatment with another investigational drug or other intervention within the study period.
20. Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Full-Dose paiTBS

10 daily sessions (50 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

experimental: Half-Dose paiTBS

5 daily sessions (25 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

Interventions

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

10 daily sessions (50 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

5 daily sessions (25 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

Primary outcome measure

  • Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates [ Time Frame: Baseline, One Month Follow Up Visit ]
  • Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates [ Time Frame: Baseline, One Month Follow Up Visit ]

Central Contacts and Locations

Central contacts

Locations

Dell Medical School at University of Texas at Austin

Recruiting

Austin, Texas, United States, 78731

Contacts

Principal Investigator:

Sean J O'Sullivan, MD, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Aug 19, 2026

Last verified

Apr, 2026

Keywords

  • Stanford Accelerated Intelligent Neuromodulation Therapy
  • SAINT
  • Transcranial Magnetic Stimulation
  • Accelerated Theta Burst Stimulation
  • Accelerated Intermittent Theta Burst Stimulation
  • TMS
  • TMS in Adolescents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-08-19.