Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Summary

This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. 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)-is effective as a first-line therapy in treating adolescents aged 13-20 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 aiTBS relieve symptoms of depression as a first-line therapy in adolescents?
* Is aiTBS a feasible option as a first-line treatment for adolescent depression?

Researchers will measure the depression symptoms in adolescent participants before and after aiTBS. 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 fMRI of their head for precision targeting
* Receive 5 days of aiTBS

Conditions

• Major Depressive Disorder
• Depression in Adolescence
• Depression
• Major Depressive Episode

Interventions

DEVICE

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

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

DEVICE

MagPro X100 edition (MagVenture, Skovlunde, Denmark)

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

Sponsors & Collaborators

• Magnus Medical

  collaborator INDUSTRY

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Sean J O'Sullivan, M.D., Ph. D. · University of Texas at Austin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2027-09-30

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations