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Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents

Study acronym: paiTBS-KID
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from University of Texas at Austin

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2026 to Sep 2027v4 Show 4 more changesShow less
    • Study completion pushed from Sep 2026 to Dec 2027
    • Start date changed from estimate of Jan 2025 to Apr 1, 2025
    • Eligibility criteria expanded, about 7 words
    • Study description shortened, about 9 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2024 to Jan 2025
    • Study sites: 0 to 1
    v3
  3. Interventions: MagPro X100 edition (MagVenture, Skovlunde, Denmark) (Device) to MagPro X100 edition (MagVenture, Skovlunde, Denmark) (Device), MagPro X100 edition (MagVenture, Skovlunde, Denmark) (Device)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06523439
Lead Sponsor University of Texas at Austin
Collaborators: Magnus Medical
Conditions
(from sponsor)		 Major Depressive Disorder, Depression in Adolescence, Depression, Major Depressive Episode
Related terms Depression, Major Depressive Disorder
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov