Actively Recruiting

Phase Not Applicable
Age: 14Years - 19Years
All Genders
NCT06523439

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Led by University of Texas at Austin · Updated on 2024-12-12

40

Participants Needed

1

Research Sites

86 weeks

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

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

Official Title

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Who Can Participate

Age: 14Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Proficient in English to complete questionnaires and follow instructions during aiTBS interventions
  • Willing to comply with all study procedures and communicate important clinical information
  • Diagnosed with Major Depressive Disorder with a current Major Depressive Episode according to DSM-5
  • No prior major depressive episodes as determined by MINI-KID
  • HAMD-17 score of 60 at screening
  • Treatment-naive with fewer than 4 weeks of antidepressant medication and fewer than 8 psychotherapy sessions in lifetime
  • TMS naive
  • Access to ongoing psychiatric care before and after the study
  • In good general health based on medical history
  • Agreement to follow Lifestyle Considerations throughout study duration
Not Eligible

You will not qualify if you...

  • Pregnancy
  • High risk for suicide or active suicidal thoughts (SIQ-JR 60 31)
  • Diagnosis of prominent anxiety disorder or dysthymia (above thresholds on SAPAS or GAD-7)
  • Current severe insomnia (must sleep at least 5 hours each night before stimulation)
  • Current mania or psychosis
  • Bipolar Affective Disorder or primary psychotic disorders
  • Autism Spectrum Disorder or Intellectual Disability
  • Diagnosis of obsessive-compulsive disorder
  • Current moderate or severe substance use disorder or signs of acute withdrawal
  • Positive urine test for illicit substances
  • History of more than 8 ECT sessions without meeting responder criteria
  • Recent or concurrent use of rapid acting antidepressants like ketamine or ECT
  • History of significant neurologic disease such as dementia, Parkinson's, brain tumor, seizures, or multiple sclerosis
  • Untreated or insufficiently treated endocrine disorders
  • Contraindications to receiving rTMS (e.g., metal in head, history of seizures, brain lesions)
  • Contraindications to MRI (ferromagnetic metal in body)
  • Any physical condition that may increase risk or interfere with study results
  • Depth-adjusted aiTBS dose above 65% maximum stimulator output
  • Treatment with another investigational drug or intervention during the study
  • Any other condition deemed by the principal investigator to interfere with the study or increase risk

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dell Medical School at University of Texas at Austin

Austin, Texas, United States, 78731

Actively Recruiting

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Research Team

E

Elyse J Lemke

CONTACT

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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