Clinical TrialPostpartum DepressionKetaminePlaceboCompleted

Low-dose S-ketamine in Women With Prenatal Depression

Randomised, parallel-group prevention trial (n=364) testing a single low-dose S-ketamine infusion (0.2 mg/kg IV) after childbirth to reduce postpartum depression in women with prenatal depression.

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

Detailed Description

This parallel, randomised, quadruple-blind study will compare a single postnatal infusion of S-ketamine (0.2 mg/kg) with placebo in women who screened positive for prenatal depression to assess incidence of postpartum depression.

The active infusion is delivered in 20 ml saline at 30 ml/h (40 minutes) with 60 minutes of monitoring; primary purpose is prevention, with outcomes including postpartum depression incidence and safety/tolerability.

Study Protocol

Preparation

sessions

Dosing

1 sessions
100 min each

Integration

sessions

Study Arms & Interventions

S-ketamine

experimental

Single intravenous infusion of S-ketamine 0.2 mg/kg after childbirth; monitored post-infusion.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    0.2 mg/kg in 20 ml saline infused at 30 ml/h (40 minutes); monitored 60 minutes post-infusion.

Placebo

inactive

Single intravenous infusion of normal saline after childbirth; monitored post-infusion.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    20 ml normal saline infused at 30 ml/h (40 minutes); monitored 60 minutes post-infusion.

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Maternal age ≥18 years;
  • 2. Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria

  • 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) syndrom, 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: 2021-08-01
  • Compounds
    KetaminePlacebo
  • 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 — Hangzhou, Zhejiang, China

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