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NCT06523439 · ClinicalTrials.gov registry record · NA
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
A NA study of Depression and Major Depressive Disorder, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06523439: Recruiting NA study of Depression and Major Depressive Disorder, sponsored by University of Texas at Austin.
NCT06523439 is a NA study of Depression and Major Depressive Disorder that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 40 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06523439, a NA study of Depression and Major Depressive Disorder, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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®)
Primary Outcome
Seventeen item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in adolescents with depression. The investigators will assess the difference in CDRS-R scores/remission rates between the full-dose paiTBS group compared to those who received half-dose paiTBS at the one-month follow up visit.
Conditions Studied
Interventions
- DEVICE MagPro X100 edition (MagVenture, Skovlunde, Denmark)
Study Locations (1)
Texas
- Dell Medical School at University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-01 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT06523439 shows while recruiting
NCT06523439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which MagPro X100 edition (MagVenture, Skovlunde, Denmark) is the first listed.
NCT06523439 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06523439 about?
NCT06523439 is a clinical study titled "Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents". 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...
What is the current status of trial NCT06523439?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-01. Estimated completion is 2026-09.
What conditions does trial NCT06523439 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Depression in Adolescence, Major Depressive Episode.
What interventions are being tested in trial NCT06523439?
The interventions under investigation include: MagPro X100 edition (MagVenture, Skovlunde, Denmark) (DEVICE).
Who is sponsoring clinical trial NCT06523439?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06523439 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06523439's enrollment target sits among peer trials
40 509th of 679 higher than 151 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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