PainPhase 1PREPARE-2NCT06767566
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
A Phase 1 study testing Ketamine (Ketalar) in people with Pain and Postpartum Depression, run by University of Utah at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postpartum Depression
- What is being tested?
- Ketamine (Ketalar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2025to 1 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Age 18 years and older
- Sex: Male or Female
- Able to provide informed consent
- ASA PS 1, 2, or 3
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Terminated
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Natalie R Bennion, MPH, 385-209-1185, natalie.bennion@utah.edu
Amy Monroe, MPH, MBA, 412-609-6161, a.monroe@utah.edu
About this study
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.
Read the detailed description
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).
- Conditions
- Pain, Postpartum Depression
- Being tested
- Ketamine (Ketalar)
- Keywords
- Cesarean Delivery
- Medical subject headings
- Pain, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (Ketalar)Drug
Also called 0.18 mg/kg/1hr loading dose Ketamine
Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusion: Cesarean Delivery Population | Experimental | Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. Receives: Drug: Ketamine (Ketalar) |
| Ketamine Infusion: Healthy Control Population | Experimental | Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. Receives: Drug: Ketamine (Ketalar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal ketamine area under the curve (AUC)
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.
Measured: 0 to 24 hours from initiation of ketamine infusion
Secondary outcomes (4)
Patient reported acceptability of any reported side effects
Proportion (%) of patient cohort reporting acceptability of ketamine infusion
Measured: 0 to 24 hours after initiation of ketamine infusion
Pain area under the curve (AUC)
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.
Measured: 0 to 24 hours after initiation of ketamine infusion
Depression scores (Peripartum)
Depression scores as defined by the Edinburgh Postnatal Depression Scale (Peripartum Group), scale 0-30, measured among the peripartum cohort.
Measured: Baseline to week 12 post-infusion
Depression Scores (control)
Depression scores as defined by the Patient Health Questionnaire (PHQ-9) (Control Group), scale 0-27, measured among the control nonperipartum cohort.
Measured: Baseline to week 12 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start30 Apr 2025
- Primary completion7 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 subjects will be cesarean delivery population 30 subjects will be Healthy Control population (N=15 nonpregnant female, N=15 male) Both groups will receive same intervention
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Grace Lim, University of Utah
- Investigators
- Grace Lim, MD, MSc, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767566
- Sponsor's protocol ID
- STUDY22100019
- Other IDs
- R01MH134538
- Acronym
- PREPARE-2
- Status last verified
- Nov 2026
- First submitted
- 21 Nov 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06767566
- Acronym / sponsor ID
- PREPARE-2 / STUDY22100019
- Conditions
- Pain, Postpartum Depression
- Keywords
- Cesarean Delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 7 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 subjects will be cesarean delivery population 30 subjects will be Healthy Control population (N=15 nonpregnant female, N=15 male) Both groups will receive same intervention
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusion: Cesarean Delivery Population | Experimental | Drug: Ketamine (Ketalar)Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. |
| Ketamine Infusion: Healthy Control Population | Experimental | Drug: Ketamine (Ketalar)Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine (Ketalar)Also: 0.18 mg/kg/1hr loading dose KetamineLoading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours | Drug | Ketamine Infusion: Cesarean Delivery Population, Ketamine Infusion: Healthy Control Population |
Primary outcome
Maternal ketamine area under the curve (AUC)
Time frame: 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.
4 secondary outcomes
Patient reported acceptability of any reported side effects
Time frame: 0 to 24 hours after initiation of ketamine infusion
Pain area under the curve (AUC)
Time frame: 0 to 24 hours after initiation of ketamine infusion
Depression scores (Peripartum)
Time frame: Baseline to week 12 post-infusion
Depression Scores (control)
Time frame: Baseline to week 12 post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace Lim, MD, MSc principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine (Ketalar) in people with Pain and Postpartum Depression, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Bennion, MPH (385-209-1185, natalie.bennion@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal ketamine area under the curve (AUC) (time frame: 0 to 24 hours from initiation of ketamine infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.