Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-20
SponsorUniversity of Texas at Austin
About this trial
This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. 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)-is effective as a first-line therapy in treating adolescents aged 13-20 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 aiTBS relieve symptoms of depression as a first-line therapy in adolescents? * Is aiTBS a feasible option as a first-line treatment for adolescent depression?
Researchers will measure the depression symptoms in adolescent participants before and after aiTBS. 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 fMRI of their head for precision targeting * Receive 5 days of aiTBS
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female, between the ages of 13 and 20 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 as determined by clinical interview
The presence or diagnosis of prominent anxiety disorder, or dysthymia (>4 on SAPAS; >16 on GAD-7)
Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
Trial design
Design model
Parallel
Treatments tested in this trial
MagPro X100 edition (MagVenture, Skovlunde, Denmark)
Device10 daily sessions (50 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
MagPro X100 edition (MagVenture, Skovlunde, Denmark)
Device5 daily sessions (25 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Full-Dose paiTBSActive comparator 1 intervention
Group B: Half-Dose paiTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
Seventeen item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in adolescents with depression. The investigators will assess the difference in CDRS-R scores/remission rates between the full-dose paiTBS group compared to those who received half-dose paiTBS at the one-month follow up visit.
Time frame
Baseline, One Month Follow Up Visit2
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
The investigators will assess the difference in CDRS-R response rates (reduction \>50% of CDRS-R baseline score) between the full-dose aiTBS group compared to those who received half-dose aiTBS.
Time frame
Baseline, One Month Follow Up VisitSponsors and contacts
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University of Texas at Austin
Lead sponsor
Magnus Medical
Collaborator
Source ClinicalTrials.gov