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Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)

Study acronym: PrEcISE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 29, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 30, 2025 to Jun 30, 2026 Completion date: Dec 1, 2025 to Dec 1, 2026v7 Show 1 more changeShow less
    • Completion date: Dec 1, 2025 to Dec 1, 2026
  2. Site contact updatedv6
  3. Site contact updatedv5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Dec 1, 2020 to Mar 8, 2021 Primary completion date: Dec 1, 2025 to Jun 30, 2025v3 Show 1 more changeShow less
    • Primary completion date: Dec 1, 2025 to Jun 30, 2025
  6. Phase: Not applicable to Phase 4 Trial status: Not Yet Recruiting to Recruiting · Primary endpoint revised · Study sites: 0 to 1 · 2 morev2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Eligibility criteria revised
    • Study description shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
University of Cincinnati
68 trials monitored
See 6 trials at risk
Anxiety
2,264 trials monitored
See 97 trials at risk
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Trial Details
NCT Number NCT04623099
Lead Sponsor University of Cincinnati
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Anxiety
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov