Status:
RECRUITING
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
Lead Sponsor:
University of Texas at Austin
Collaborating Sponsors:
Magnus Medical
Conditions:
Major Depressive Disorder
Depression in Adolescence
Eligibility:
All Genders
14-19 years
Phase:
NA
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 transcr...
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®) techn...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Contraindications to MRI (ferromagnetic metal in their body).
- 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.
- Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO)
- Treatment with another investigational drug or other intervention within the study period.
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06523439
Start Date
January 1 2025
End Date
September 1 2026
Last Update
December 12 2024
Active Locations (1)
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1
Dell Medical School at University of Texas at Austin
Austin, Texas, United States, 78731