Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

NCT06523439 | Recruiting FDA Device

• 1 other identifier: NECMHR01-FY24-032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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®)

Conditions

Major Depressive Disorder; Depression in Adolescence; Depression; Major Depressive Episode

Keywords

Stanford Accelerated Intelligent Neuromodulation Therapy; SAINT; Transcranial Magnetic Stimulation; Accelerated Theta Burst Stimulation; Accelerated Intermittent Theta Burst Stimulation; TMS; TMS in Adolescents

Outcome Measures

Primary Outcomes (2)

• Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates

  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 Standard SAINT® group compared to those who received Truncated SAINT® at the one-month follow up visit.

  Baseline, One Month Follow Up Visit

• Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates

  The investigators will assess the difference in CDRS-R response rates (reduction \>50% of CDRS-R baseline score) between the Standard SAINT® group compared to those who received Truncated SAINT®.

  Baseline, One Month Follow Up Visit

Study Arms (2)

Standard SAINT®

ACTIVE COMPARATOR

10 daily sessions (50 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), 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)

Truncated SAINT®

EXPERIMENTAL

5 daily sessions (25 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), 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)

Interventions

MagPro X100 edition (MagVenture, Skovlunde, Denmark) DEVICE

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).

Also known as: Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with Magnus Neuromodulation System (MNS)

Standard SAINT®

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or Female, between the ages of 14 and 19 at the time of screening.
• Able to read, understand, and provide written, dated assent and/or consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
• Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
• No prior major depressive episodes (MDEs) as determined by MINI-KID
• HAMD-17 score of ≥20 at screening (Visit 1).
• Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 4 weeks of antidepressant medication and fewer than 8 psychotherapy sessions in lifetime; willingness to taper medications and stop psychotherapy if recently started and within the window defined above.)
• TMS naive.
• Access to ongoing psychiatric care before and after completion of the study.
• In good general health, as evidenced by medical history.
• Agreement to adhere to Lifestyle Considerations throughout study duration.

You may not qualify if:

• Pregnancy
• High-risk for suicide or active suicidal ideation (Suicidal Ideation Questionnaire- Junior \[SIQ-JR\] ≥ 31).
• The presence or diagnosis of prominent anxiety disorder, or dysthymia (\>3 on SAPAS; \>10 on GAD-7)
• Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
• Current mania or psychosis
• Bipolar Affective Disorder and/or primary psychotic disorders.
• Autism Spectrum disorder or Intellectual Disability
• A diagnosis of obsessive-compulsive disorder (OCD)
• Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
• Urine screening test positive for illicit substances.
• Any history of ECT (greater than 8 sessions) without meeting responder criteria
• Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
• History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
• Untreated or insufficiently treated endocrine disorder.
• Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)

Sponsors & Collaborators

• University of Texas at Austin: lead
• Magnus Medical: collaborator

Study Sites (1)

Dell Medical School at University of Texas at Austin

Austin, Texas, 78731, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sean J O'Sullivan, M.D., Ph. D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elyse J Lemke

CONTACT

512-495-5566; elyse.lemke@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters will be blinded as to whether the adolescent participants received Standard SAINT® (10 TMS treatments per day for 5 days) or Truncated SAINT® (5 TMS treatments per day for 5 days).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)