Clinical TrialPostpartum DepressionPlaceboPlaceboKetaminePlaceboPlaceboKetamineCompleted

Ketamine to Prevent PPD After Cesarean

Randomised, parallel pilot study (n=25 actual) testing ketamine 0.5 mg/kg by subcutaneous injection or 40-minute IV infusion versus saline placebo to prevent postpartum depression after cesarean, with 42-day follow-up.

Target Enrollment
25 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

Postpartum depression (PPD) is a common perinatal complication with significant maternal and infant consequences; routine screening is recommended and prevention strategies are needed.

Ketamine has rapid antidepressant effects in non‑pregnant populations; intravenous 0.5 mg/kg over 40 minutes is commonly used and subcutaneous administration is an alternative route under investigation.

This randomised, quadruple‑blind, parallel pilot trial randomises participants undergoing cesarean to one of three groups (SC ketamine, IV ketamine, or placebo) to assess feasibility, tolerability and preliminary incidence of PPD over 42 days.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Control

inactive

Subcutaneous injection and 40-minute IV infusion of 0.9% sodium chloride (placebo) shortly after cesarean delivery.

Interventions

  • Placebo
    via Other• single dose

    Subcutaneous injection of 0.9% sodium chloride.

  • Placebo
    via IV• single dose

    40-minute IV infusion of 0.9% sodium chloride.

Ketamine SC

experimental

Subcutaneous ketamine 0.5 mg/kg plus IV saline infusion.

Interventions

  • Ketamine0.5 mg/kg
    via Other• single dose

    Subcutaneous ketamine 0.5 mg/kg administered shortly after cesarean.

  • Placebo
    via IV• single dose

    40-minute IV infusion of 0.9% sodium chloride.

Ketamine IV

experimental

40-minute IV ketamine infusion 0.5 mg/kg plus subcutaneous saline injection.

Interventions

  • Placebo
    via Other• single dose

    Subcutaneous injection of 0.9% sodium chloride.

  • Ketamine0.5 mg/kg
    via IV• single dose

    40-minute IV infusion of ketamine 0.5 mg/kg.

Participants

Ages
18 – 45
Sexes
female

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

Study Details

Locations

Washington University in St. Louis — St Louis, Missouri, United States

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