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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 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.

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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®)

Interventions

  • DEVICE MagPro X100 edition (MagVenture, Skovlunde, Denmark)

Study Locations (1)

Texas

  • Dell Medical School at University of Texas at Austin - Austin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-01
Est. Completion 2026-09
Phase NA

Sponsor

University of Texas at Austin

257 total trials

What the Registry Record Tells You About NCT06523439

The ClinicalTrials.gov registry entry for NCT06523439 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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