~33 spots leftby Dec 2027

Ketamine for Postpartum Depression

(PREPARE-2 Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byGrace Lim, MD, MSc
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Grace Lim, MD, MS
No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for women who have just given birth by cesarean section and are experiencing postpartum depression or pain. It aims to understand how ketamine, used here for its potential mood-lifting and pain-relieving effects, behaves in the body after pregnancy. Non-pregnant women and men will serve as controls to compare results.

Inclusion Criteria

* Cesarean delivery
* Adults 18 years and older
* Term delivery ≥ 37 weeks gestation anticipated at time of delivery
See 3 more

Treatment Details

Interventions

  • Ketamine (NMDA Receptor Antagonist)
Trial OverviewThe study is testing how ketamine (Ketalar) is processed by the body (pharmacokinetics) and its effects (pharmacodynamics) in new mothers following a cesarean delivery compared to non-pregnant control subjects. The goal is to see if there's a difference in drug behavior due to post-pregnancy physiology.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Ketamine Infusion: Healthy Control PopulationExperimental Treatment1 Intervention
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Group II: Ketamine Infusion: Cesarean Delivery PopulationExperimental Treatment1 Intervention
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
UPMC Montefiore Clinical and Translational Research CenterPittsburgh, PA
Magee Womens Hospital of UPMCPittsburgh, PA
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Who Is Running the Clinical Trial?

Grace Lim, MD, MSLead Sponsor
National Institute of Mental Health (NIMH)Collaborator

References