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Neural Biomarkers of Electroconvulsive Therapy Response

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 1, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Collaborator revisedv6 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv5
  4. Phase: Not specified to Not applicable Primary endpoint revised · Eligibility criteria shortened, about 11 words · Secondary endpoints revised (3) · 1 morev4 Show 4 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints revised (3)
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Early Phase 1 to Not specified Primary completion date: Dec 1, 2023 to Dec 1, 2024 · Completion date: Jul 1, 2024 to Jul 1, 2025v3 Show 2 more changesShow less
    • Primary completion date: Dec 1, 2023 to Dec 1, 2024
    • Completion date: Jul 1, 2024 to Jul 1, 2025
  6. Phase: Not specified to Early Phase 1v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.
Trial Details
NCT Number NCT04763655
Lead Sponsor Northwell Health
Collaborators: National Institutes of Health (NIH)
Conditions Electroconvulsive Therapy Treated Patients
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov