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EMA-Guided Maintenance TMS for Depression

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 4, 2024 (before its estimated September 25, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  2. Eligibility criteria expanded, about 1 word
    • Study description expanded, about 2 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Butler Hospital
30 trials monitored
See 1 trial at risk
Depression
3,055 trials monitored
See 173 trials at risk
The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.
Trial Details
NCT Number NCT06145594
Lead Sponsor Butler Hospital
Conditions
(from sponsor)		 Major Depressive Disorder
Related terms Major Depressive Disorder
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov