Clinical TrialPostpartum DepressionEsketaminePlaceboCompleted

Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression

This study is designed to investigate whether low-dose s-ketamine administered after childbirth can reduce the incidence of postpartum depression in parturients with prenatal depression.

Target Enrollment
364 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, parallel-group prevention trial in parturients with prenatal depression testing a single post‑delivery IV infusion of low‑dose S‑ketamine (0.2 mg/kg) versus saline placebo.

Primary aim is reduction in incidence of postpartum depression; participants receive infusion after childbirth and are monitored for safety (60 minutes) with follow-up assessments for depressive symptoms.

Study Protocol

Preparation

sessions

Dosing

1 sessions
100 min each

Integration

sessions

Study Arms & Interventions

S-ketamine

experimental

Single IV infusion of low-dose S-ketamine (postpartum) with 60 min monitoring.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    0.2 mg/kg in 20 ml normal saline infused over 40 minutes; monitored 60 minutes post-infusion.

Placebo

placebo

Single IV infusion of normal saline with 60 min monitoring.

Interventions

  • Placebo
    via IV• single dose

    20 ml normal saline infused over 40 minutes; monitored 60 minutes post-infusion.

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • Parturients with age ≥18 years;
  • Presence of prenatal depression (EPDS score ≥10);

Exclusion Criteria

  • 1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
  • 2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrome, placenta previa, and placental abruption;
  • 3. American Society of Anesthesiologists classification ≥III;
  • 4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment364 participants
  • Timeline
    Start: 2020-06-19
    End: 2022-08-01
  • Compounds
    EsketaminePlacebo
  • Topic
    Postpartum Depression

Locations

Peking University First Hospital — Beijing, Beijing Municipality, China
Beijing Tiantan Hospital — Beijing, Beijing Municipality, China
Peking University International Hospital — Beijing, Beijing Municipality, China
Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China
Huaian Maternal and Child Health Care Hospital — Huaian, Jiangsu, China
Nanjing Maternal and Child Health Care Hospital — Nanjing, Jiangsu, China
Women's Hospital School Of Medicine Zhejiang University — Hanzhou, Zhejiang, China

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