Magnetic brain pulses could offer Drug-Free hope for teen depression
NCT ID NCT06523439
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests whether a new form of transcranial magnetic stimulation (TMS), called accelerated intermittent theta burst stimulation (aiTBS), can ease depression in adolescents aged 13-20 who haven't yet tried other treatments. Participants receive five days of aiTBS sessions, guided by brain scans, and stay off antidepressants during the study. Researchers will measure depression symptoms before and after treatment to see if aiTBS is both effective and acceptable as a first-line therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- accelerated intermittent theta burst stimulation (aiTBS), a form of transcranial magnetic stimulation (TMS)
- What this could lead to
- If it works, this could offer a drug-free first-line option for teens with depression, potentially easing symptoms without the side effects of antidepressants.
- What could go wrong
- This is a small, early-stage trial, so results may not apply broadly. TMS can cause scalp discomfort or headache, and the treatment may not relieve depression for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 20 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Dell Medical School at University of Texas at Austin
RECRUITINGAustin, Texas, 78731, United States
Contact Email: •••••@•••••
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