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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery

Study acronym: PREPARE-2
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment resumed after suspension Study sites: 1 to 2 · Eligibility criteria expanded, about 39 words Show 2 more changesShow less
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 39 words
  2. Lead sponsor: Grace Lim, MD, MS to University of Utahv6
  3. Recruitment suspended Sponsor's reason: Study is paused while preparing for implementation at IND Sponsor's new institution Study sites: 2 to 1v5 Show 1 more changeShow less
    • Study sites: 2 to 1
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 30, 2025 to Mar 28, 2025 · Site details revised at 2 of 2 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 30, 2025 to Mar 28, 2025
    • Site details revised at 2 of 2 sites
  6. Start date: Feb 7, 2025 to Apr 30, 2025 Site contacts updated at 2 of 2 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics. The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.
Trial Details
NCT Number NCT06767566
Lead Sponsor University of Utah
Collaborators: National Institute of Mental Health (NIMH)
Conditions Pain, Postpartum Depression
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov