RecruitingNot ApplicableNCT06523439

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Investigating a Truncated Version of SAINT in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial

Sponsor

University of Texas at Austin

Enrollment

40 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Major Depressive Disorder Depression in Adolescence Major Depressive Episode

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

Min Age: 14 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether an intensive brain stimulation treatment called accelerated intermittent theta burst stimulation (aiTBS) — a type of non-invasive magnetic brain stimulation — can help teenagers and young adults experiencing their first episode of major depression who have never been on antidepressants. **You may be eligible if...** - You are between 14 and 19 years old - You have been diagnosed with Major Depressive Disorder (MDD) and are currently in a depressive episode - This is your first depressive episode (no prior episodes) - You have a depression severity score of at least 20 on a standard rating scale (HAMD-17) - You have never had a full course of antidepressant medication or psychotherapy - You have not previously received TMS (transcranial magnetic stimulation) - You have access to ongoing psychiatric care - You are able to read and understand English **You may NOT be eligible if...** - You are pregnant - You are actively suicidal or at high risk of suicide - You have a significant anxiety disorder, dysthymia, bipolar disorder, or psychosis - You have severe insomnia (sleeping less than 5 hours per night) - You have autism, intellectual disability, or OCD - You have a current moderate or severe substance use disorder - You are currently using ketamine or another fast-acting antidepressant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagPro X100 edition (MagVenture, Skovlunde, Denmark)

10 daily sessions (50 total over 5-days) of SAINT® (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).

DEVICEMagPro X100 edition (MagVenture, Skovlunde, Denmark)

5 daily sessions (25 total over 5-days) of SAINT® (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).