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

NCT06767566 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY22100019R01MH134538
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pain; Postpartum Depression

Keywords

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  0 to 24 hours from initiation of ketamine infusion

Secondary Outcomes (4)

• Patient reported acceptability of any reported side effects

  0 to 24 hours after initiation of ketamine infusion

• Pain area under the curve (AUC)

  0 to 24 hours after initiation of ketamine infusion

• Depression scores (Peripartum)

  Baseline to week 12 post-infusion

• Depression Scores (control)

  Baseline to week 12 post-infusion

Study Arms (2)

Ketamine Infusion: Cesarean Delivery Population

EXPERIMENTAL

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.

Drug: Ketamine (Ketalar)

Ketamine Infusion: Healthy Control Population

EXPERIMENTAL

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.

Drug: Ketamine (Ketalar)

Interventions

Ketamine (Ketalar) DRUG

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

Also known as: 0.18 mg/kg/1hr loading dose Ketamine

Ketamine Infusion: Cesarean Delivery Population; Ketamine Infusion: Healthy Control Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Grace Lim, MD, MS: lead

Study Sites (2)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Montefiore Clinical and Translational Research Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pain; Depression, Postpartum

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Grace Lim, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

4126236382; monroeal@upmc.edu

Alexandra Anderson, BS

CONTACT

4126414154; andersonah2@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Chief Obstetric & Women's Anesthesiology

Model Details: 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

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 10, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning with 3 months and ending at 5 years following article publication.
• Access Criteria: 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.

Locations

US (2)