New treatment for depression in adolescents using brain stimulation

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

This study is testing a new brain stimulation treatment for depression in teens aged 14-19 who haven't tried antidepressants before, to see if it helps them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 14 Years to 19 Years
• Sex: All
• Sponsor: University of Texas at Austin (Academic / other)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06523439 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) in treating major depressive disorder in adolescents aged 14-19 who have not previously received antidepressant treatment. Participants will undergo a series of transcranial magnetic stimulation sessions aimed at reducing depressive symptoms, with their progress monitored through standardized depression rating scales. The study will also gather feedback from both adolescents and their parents regarding the treatment's acceptability as a first-line option for depression. The trial aims to enroll approximately 40 participants and will assess outcomes at baseline and one month post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 14-19 who are experiencing their first episode of major depressive disorder and have not previously been treated with antidepressants.

Not a fit: Patients with a history of major depressive episodes or those who have previously undergone adequate antidepressant trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective first-line therapy for adolescents suffering from major depressive disorder.

How similar studies have performed: Previous studies using similar transcranial magnetic stimulation techniques in adults have shown promising results, suggesting potential for success in this adolescent population.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Austin, Texas

• Dell Medical School at University of Texas at Austin — Austin, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sean J O'Sullivan, M.D., Ph. D. — University of Texas at Austin
• Study coordinator: Elyse J Lemke

Conditions Major Depressive Disorder; Depression in Adolescence; Depression; Major Depressive Episode; Stanford Accelerated Intelligent Neuromodulation Therapy; SAINT; Transcranial Magnetic Stimulation; Accelerated Theta Burst Stimulation