Postpartum Depression Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

• Age 18 years and older

• Sex: Male or Female

• Able to provide informed consent

• ASA PS 1, 2, or 3

Locations
United States
Pennsylvania
Magee Womens Hospital of UPMC
RECRUITING
Pittsburgh
UPMC Montefiore Clinical and Translational Research Center
RECRUITING
Pittsburgh
Contact Information
Primary
Amy Monroe, MPH, MBA
monroeal@upmc.edu
4126236382
Backup
Alexandra Anderson, BS
andersonah2@upmc.edu
4126414154
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2028-03
Participants
Target number of participants: 50
Treatments
Experimental: Ketamine Infusion: Cesarean Delivery Population
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Experimental: Ketamine Infusion: Healthy Control Population
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Related Therapeutic Areas
Sponsors
Leads: Grace Lim, MD, MS
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov