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CompletedPhase 3Results posted

Ketamine to Prevent PPD After Cesarean

NCT04227704 · PoCKet · Washington University School of Medicine

Closed to entry
Status
Not accepting participants
Phase 3
Phase
25
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30

    Measured over 42 days postpartum

  • Percentage of Eligible Patients Consenting to Participation

    Measured over Through study completion, approximately 9 months

  • Percentage of Patients With a Complete Dataset

    Measured over Through study completion, approximately 9 months

  • Number of Patients in Study Arms Experiencing One or More Severe Side Effects

    Measured over Through study completion, approximately 9 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion criteria: * Term pregnancy * Age 18-45 years of age * Scheduled cesarean delivery under neuraxial anesthesia Exclusion criteria: * ASA classification IV or V * History of psychotic episodes * History of allergy to ketamine * Inability to communicate in English or any other barrier to providing informed consent

Where

1 study site

FacilityCityRegionCountry
Washington University in St. LouisSt LouisMissouriUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04227704 on ClinicalTrials.gov →

Last updated in the registry 2023-01-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits