Actively Recruiting
Investigating a Truncated Version of SAINT in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial
Led by University of Texas at Austin · Updated on 2024-12-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas at Austin
Lead Sponsor
M
Magnus Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT4) protocol, a new form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS), for treating adolescents aged 14-19 years experiencing their first episode of major depressive disorder (MDD). This open-label clinical trial aims to see if SAINT4 can relieve depression symptoms and be a feasible first-line therapy for adolescents who have not undergone prior full depression treatment and remain antidepressant-free during the trial. Participants will receive one of two SAINT4 treatment regimens delivered via a MagPro X100 TMS device with a Cool-B65 A/P coil. One group will receive 10 daily sessions (50 total) over 5 days, while the other will receive 5 daily sessions (25 total) over 5 days. Each session involves bursts of magnetic stimulation targeted to a specific brain area identified by MRI. Sessions last about 10 minutes with 50-minute breaks between them, delivered at 90% of resting motor threshold adjusted for scalp-to-cortex distance. During the study, adolescents will remain antidepressant-free for 6-7 weeks, undergo an MRI for precise treatment targeting, and attend all study visits. Researchers will assess depressive symptoms using rating scales at baseline and one month after treatment. Parents will also provide feedback on the acceptability of SAINT4 as a first treatment option. Safety and feasibility will be closely monitored throughout the trial's duration, which runs until September 2026.
CONDITIONS
Brief Title
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 14 to 19 years at screening
- Able to read, understand, and provide written consent or assent
- Diagnosed with major depressive disorder (MDD) with a current major depressive episode
- No prior major depressive episodes
- HAMD-17 score of 20 or higher at screening
- Treatment-naive (fewer than 4 weeks of antidepressant medication and fewer than 8 psychotherapy sessions ever)
- TMS naive
- Access to ongoing psychiatric care before and after the study
- In good general health
- Agree to follow lifestyle considerations during the study
You will not qualify if you...
- Pregnancy
- High risk of suicide or active suicidal thoughts
- Prominent anxiety disorder or dysthymia
- Severe insomnia (less than 5 hours sleep nightly)
- Current mania or psychosis
- Bipolar disorder or primary psychotic disorders
- Autism spectrum disorder or intellectual disability
- Obsessive-compulsive disorder
- Moderate or severe substance use disorder or acute withdrawal signs
- Positive urine test for illicit substances
- History of more than 8 ECT sessions without response
- Recent or current use of rapid-acting antidepressants (e.g., ketamine, ECT)
- Significant neurologic diseases or brain injury
- Untreated or insufficiently treated endocrine disorders
- Contraindications to rTMS or MRI
- Any physical condition that may increase risk or affect results
- Treatment dose exceeding 65% maximum stimulator output
- Treatment with another investigational drug or intervention during the study
- Any other condition deemed unsafe or interfering by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive SAINT® stimulation sessions targeting the left dorsolateral prefrontal cortex. The treatment consists of either 5 or 10 daily sessions over 5 consecutive days, with each session lasting about 10 minutes and 50-minute breaks between sessions.
Daily visits for 5 days
Duration - 1 month after treatment
Participants attend follow-up visits to assess changes in depressive symptoms using rating scales and provide feedback on treatment preference.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Dell Medical School at University of Texas at Austin
Austin, Texas, United States, 78731
Actively Recruiting
Research Team
E
Elyse J Lemke
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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