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Ketamin farmakokinetik og farmakodynamik til postpartum depression og smerter efter kejsersnit (PREPARE-2)

4. november 2026 opdateret af: Grace Lim, University of Utah

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A lack of data on new pain treatments in pregnancy puts 1.2 million US women having cesarean delivery (CD) every year at risk for poor pain control, depressed mood, and poor recovery. Evidence of successful post-surgical pain management and rapid reduction of depressive symptoms render ketamine a great candidate for post-CD pain management and potential reduction of postpartum depression (PPD) symptomology. Knowledge gaps in ketamine pharmacokinetics (PK) in the postpartum period limit an informed approach to its use for postpartum analgesia and PPD mitigation strategies. Similarly, knowledge gaps about sex differences in ketamine PK limit understandings about potential heterogeneity of treatment effects. This study aims to better understand the pharmacokinetics and pharmacodynamics of ketamine in postpartum women. Secondarily, it will assess key differences in postpartum ketamine PK compared to non-pregnant female controls. Secondarily it will assess key sex differences in ketamine metabolism between male and female subjects.

Peripartum females undergoing cesarean delivery will receive a ketamine infusion for 12 hours after cord clamping. Samples will be taken to characterize ketamine PK (primary objective). Healthy volunteer control females and males will receive the same ketamine infusion dosing schematic. Comparisons will be made between peripartum females and non-pregnant female controls, and between female and male controls (secondary objectives).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Afsluttet
        • Magee Womens Hospital of UPMC
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Rekruttering
        • University of Utah
        • Ledende efterforsker:
          • Grace Lim, MD, MSc
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Peripartum Participants:

Inclusion Criteria

  • Cesarean delivery
  • Adults 18 years and older
  • Term delivery ≥ 37 weeks gestation anticipated at time of delivery
  • ASA PS 2 or 3
  • Able to provide informed consent
  • One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan.

Exclusion Criteria

  • Patient going under general anesthesia for cesarean delivery
  • Allergy to study medication (ketamine)
  • ASA PS 4 +
  • Contraindications to neuraxial anesthesia
  • Preterm delivery (<37 weeks gestation)
  • Anticipated fetal-neonatal complex care plan as indicated in the patient's chart
  • Patient history of ketamine or PCP abuse
  • Patient history of schizophrenia or psychosis
  • Patient history of liver or renal insufficiency
  • Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
  • Participating in another pain or depression intervention trial
  • Undergoing hormonal or gender affirming therapies
  • Pre-eclampsia with severe features
  • Hemodynamic instability
  • Inability to participate in study procedures for any reason
  • Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)

Control Participants

Inclusion Criteria

  • Age 18 years and older
  • Sex: Male or Female
  • Able to provide informed consent
  • ASA PS 1, 2, or 3

Exclusion Criteria

  • Allergy to study medication (ketamine)
  • ASA PS 4 +
  • Inability to participate in study procedures for any reason
  • Patient history of ketamine or PCP abuse
  • Patient history of schizophrenia or psychosis
  • Patient history of liver or renal insufficiency
  • Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
  • Participating in another pain or depression intervention trial
  • Hemodynamic instability
  • Pregnant or pregnant within the last 6 weeks
  • Unwilling to provide urine sample for pregnancy testing (female controls)
  • Undergoing hormonal or gender affirming therapies
  • Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ketamine Infusion: Cesarean Delivery Population

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Medicin: Ketamine (Ketalar)

Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours

Andre navne:
  • 0,18 mg/kg/1 time startdosis Ketamin
Eksperimentel: Ketamine Infusion: Healthy Control Population

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Medicin: Ketamine (Ketalar)

Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours

Andre navne:
  • 0,18 mg/kg/1 time startdosis Ketamin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal ketamine area under the curve (AUC)
Tidsramme: 0 to 24 hours from initiation of ketamine infusion

Ketamine area under the plasma concentration-time curve (AUC 0-∞) (AUC, mcg*min/mL), which reflects the actual body exposure to ketamine after administration of ketamine.
0 to 24 hours from initiation of ketamine infusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient reported acceptability of any reported side effects
Tidsramme: 0 to 24 hours after initiation of ketamine infusion

Proportion (%) of patient cohort reporting acceptability of ketamine infusion
0 to 24 hours after initiation of ketamine infusion
Pain area under the curve (AUC)
Tidsramme: 0 to 24 hours after initiation of ketamine infusion

Pain score area under the curve (AUC) where pain scores are measured from 0 (no pain) to 10 (worst imaginable pain), for the duration of epidural analgesia.
0 to 24 hours after initiation of ketamine infusion
Depression scores (Peripartum)
Tidsramme: Baseline to week 12 post-infusion

Depression scores as defined by the Edinburgh Postnatal Depression Scale (Peripartum Group), scale 0-30, measured among the peripartum cohort.
Baseline to week 12 post-infusion
Depression Scores (control)
Tidsramme: Baseline to week 12 post-infusion

Depression scores as defined by the Patient Health Questionnaire (PHQ-9) (Control Group), scale 0-27, measured among the control nonperipartum cohort.
Baseline to week 12 post-infusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Grace Lim, MD, MSc, University of Utah

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2025

Primær færdiggørelse (Anslået)

7. december 2027

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

21. november 2024

Først indsendt, der opfyldte QC-kriterier

8. januar 2025

Først opslået (Faktiske)

10. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY22100019
  • R01MH134538 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified data will be available for public benefit and knowledge. Items for uploading will include clinical measures, patient reported outcomes, psychometric testing data, sensory testing data, and all PK data. Technical protocols and any other data collected under this project will be shared upon request to allow others to perform secondary analyses.

IPD-delingstidsramme

Beginning with 3 months and ending at 5 years following article publication.

IPD-delingsadgangskriterier

Researchers who propose a methodologically sound proposal may submit said proposals to limkg2@upmc.edu. To gain access to data, requestors will need to sign a data access agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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