RECRUITING

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Conditions

Major Depressive Disorder Depression in Adolescence Depression Major Depressive Episode Stanford Accelerated Intelligent Neuromodulation Therapy SAINT Transcranial Magnetic Stimulation Accelerated Theta Burst Stimulation Accelerated Intermittent Theta Burst Stimulation TMS TMS in Adolescents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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®)

Official Title

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

Quick Facts

Study Start:2025-01

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06523439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or Female, between the ages of 14 and 19 at the time of screening. 2. 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. 3. 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). 4. No prior major depressive episodes (MDEs) as determined by MINI-KID 5. HAMD-17 score of ≥20 at screening (Visit 1). 6. 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.) 7. TMS naive. 8. Access to ongoing psychiatric care before and after completion of the study. 9. In good general health, as evidenced by medical history. 10. Agreement to adhere to Lifestyle Considerations throughout study duration.	1. Pregnancy 2. High-risk for suicide or active suicidal ideation (Suicidal Ideation Questionnaire- Junior \[SIQ-JR\] ≥ 31). 3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (\>3 on SAPAS; \>10 on GAD-7) 4. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation) 5. Current mania or psychosis 6. Bipolar Affective Disorder and/or primary psychotic disorders. 7. Autism Spectrum disorder or Intellectual Disability 8. A diagnosis of obsessive-compulsive disorder (OCD) 9. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal. 10. Urine screening test positive for illicit substances. 11. Any history of ECT (greater than 8 sessions) without meeting responder criteria 12. Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT). 13. 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. 14. Untreated or insufficiently treated endocrine disorder. 15. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) 16. Contraindications to MRI (ferromagnetic metal in their body). 17. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. 18. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO) 19. Treatment with another investigational drug or other intervention within the study period. 20. Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

Inclusion Criteria

Exclusion Criteria

1. Male or Female, between the ages of 14 and 19 at the time of screening.
2. 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.
3. 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).
4. No prior major depressive episodes (MDEs) as determined by MINI-KID
5. HAMD-17 score of ≥20 at screening (Visit 1).
6. 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.)
7. TMS naive.
8. Access to ongoing psychiatric care before and after completion of the study.
9. In good general health, as evidenced by medical history.
10. Agreement to adhere to Lifestyle Considerations throughout study duration.

1. Pregnancy
2. High-risk for suicide or active suicidal ideation (Suicidal Ideation Questionnaire- Junior \[SIQ-JR\] ≥ 31).
3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (\>3 on SAPAS; \>10 on GAD-7)
4. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
5. Current mania or psychosis
6. Bipolar Affective Disorder and/or primary psychotic disorders.
7. Autism Spectrum disorder or Intellectual Disability
8. A diagnosis of obsessive-compulsive disorder (OCD)
9. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
10. Urine screening test positive for illicit substances.
11. Any history of ECT (greater than 8 sessions) without meeting responder criteria
12. Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
13. 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.
14. Untreated or insufficiently treated endocrine disorder.
15. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
16. Contraindications to MRI (ferromagnetic metal in their body).
17. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
18. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO)
19. Treatment with another investigational drug or other intervention within the study period.
20. Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

Contacts and Locations

Study Contact

Elyse J Lemke

CONTACT

512-495-5566

elyse.lemke@austin.utexas.edu

Principal Investigator

Sean J O'Sullivan, M.D., Ph. D.

PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Study Locations (Sites)

Dell Medical School at University of Texas at Austin

Austin, Texas, 78731

United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-01

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Major Depressive Disorder
Depression in Adolescence
Depression
Major Depressive Episode