NCT06523439 Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
| NCT ID | NCT06523439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. 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) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 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 SAINT® relieve symptoms of depression as a first-line therapy in adolescents? * Is SAINT® a feasible option as a first-line treatment for adolescent depression? Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. 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 MRI of their head for precision targeting * Receive 5 days of aiTBS (SAINT®)
Eligibility Criteria
Inclusion Criteria: 1. Male or Female, between the ages of 14 and 19 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. HAMD-17 score of ≥20 at screening (Visit 1). 6. Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 4 weeks of antidepressant medication and fewer than 8 psychotherapy sessions in lifetime; 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 (Suicidal Ideation Questionnaire- Junior \[SIQ-JR\] ≥ 31). 3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (\>3 on SAPAS; \>10 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.
Contact & Investigator
Sean J O'Sullivan, M.D., Ph. D.
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT06523439 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 19 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523439 currently recruiting?
Yes, NCT06523439 is actively recruiting participants. Contact the research team at elyse.lemke@austin.utexas.edu for enrollment information.
Where is the NCT06523439 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06523439 clinical trial?
NCT06523439 is sponsored by University of Texas at Austin. The principal investigator is Sean J O'Sullivan, M.D., Ph. D. at University of Texas at Austin. The trial plans to enroll 40 participants.