NCT06523439

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 14 Years – 19 Years
• Healthy volunteers: Not accepted

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®)

Detailed description

This single-site open-label clinical trial aims to test the safety and efficacy of the Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) technology in treatment-naive adolescents with major depressive disorder (MDD) who remain antidepressant-free throughout the treatment. The SAINT® protocol, or a truncated version (5 or 10 applications per day to a customized target within the left dorsolateral prefrontal cortex \[L-DLPFC\] identified with fMRI for five consecutive days), in combination with MNS software will be delivered to each adolescent participant. Changes in depressive symptoms will be measured at baseline and two follow up visits. Additionally, parents and adolescents will answer questions regarding their preference for SAINT® as a first-line treatment option for MDD. The hypothesis is that adolescent participants receiving SAINT® or the truncated version will demonstrate similar response and remission rates that are comparable to SAINT® trials in adults (80-90%) as measured by the Childhood Depression Rating Scale (CDRS) and Hamilton Depression Rating Scale. The primary objective of this study is to determine the efficacy of active SAINT® in reducing symptoms of depression as measured by the CDRS at the one-month follow up time point. The study will enroll approximately 40 participants and employ a two-arm design with 20 participants per arm. The target population is adolescents of all genders and ethnicities who are between 14 and 19 years of age with a diagnosis of MDD experiencing their first major depressive episode who have not received a full course of prior treatment and who are otherwise in good general health. Participants must be without contraindications to Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS) and must be able to attend all study visits. This study will deliver SAINT® via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 5 or 10 daily sessions (25 or 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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	MagPro 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).
DEVICE	MagPro 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).

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-07-26
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study