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NCT Number: NCT03927378

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

Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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About this study

Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
  • 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;
  • American Society of Anesthesiologists classification ≥III;
  • Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.

Treatment and study plan

S-ketamine

Drug

S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.

Other names: S-ketamine hydrochloride

Placebo

Drug

Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.

Other names: Normal saline

Primary outcomes

  1. The incidence of depression at 42 days after childbirth.

    Time frame: At 42 days after childbirth.

    PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.

Secondary outcomes

  1. Maternal depression score at 7 days postpartum.

    Time frame: At 7 days after childbirth.

    Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.

  2. Maternal depression score at 42 days postpartum.

    Time frame: At 42 days after childbirth.

    Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.

  3. Maternal depression severity at 42 days postpartum.

    Time frame: At 42 days after childbirth.

    Maternal depression severity will be assessed with the Hamilton Depression Scale-17

  4. Intensity of pain at 1, 7, and 42 days postpartum.

    Time frame: At 1, 7, and 42 days after childbirth.

    Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).

  5. Maternal breast feeding at 1, 7, and 42 days postpartum.

    Time frame: At 1, 7, and 42 days after childbirth.

    The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.

  6. Length of hospital stay after giving birth.

    Time frame: Up to 30 days after giving birth.

    Length of hospital stay after giving birth.

  7. Incidence of maternal complications within 42 days postpartum.

    Time frame: Up to 42 days after giving birth.

    Maternal complications are defined as those that are harmful to maternal health and require medical intervention.

  8. Incidence of neonatal diseases within 42 days.

    Time frame: Up to 42 days after birth.

    Neonatal diseases are defined as those that require medical intervention.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Hunan Provincial Maternal and Child Health Care Hospital
  • Nanjing Medical University
  • Peking University International Hospital
  • Women's Hospital School Of Medicine Zhejiang University

Registry information

Official study title

Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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