Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorUniversity of Texas at Austin
About this trial
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®)
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MagPro X100 edition (MagVenture, Skovlunde, Denmark)
- MagPro X100 edition (MagVenture, Skovlunde, Denmark)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas at Austin
Lead sponsor
Magnus Medical
Collaborator
Source ClinicalTrials.gov