Low-dose S-ketamine in Women With Prenatal Depression

Ketamine

Brief Summary

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.

Intervention / Treatment

  • S-ketamine (DRUG)
    For women in this group, active drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
  • Placebo (DRUG)
    For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.

Condition or Disease

  • Prenatal Depression
  • Ketamine
  • Postpartum Depression

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 364 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 19, 2020 ACTUAL
    Primary Completion: Aug 03, 2022 ACTUAL
    Completion Date: Aug 03, 2022 ACTUAL
    Study First Posted: Jun 04, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 01, 2023

    Sponsors / Collaborators

    Lead Sponsor: Peking University First Hospital
    Responsible Party: N/A

    Location

    Jiangsu, China
    Beijing, China
    Changsha, Hunan, China
    Nanjing, Jiangsu, China

    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.

    Participant Groups

    • For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.

    • For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

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

    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.

    Primary Outcomes

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

    Secondary Outcomes

    • 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.

    • 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.

    • Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.

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

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

    • Length of hospital stay after giving birth.

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

    • Neonatal diseases are defined as those that require medical intervention.

    More Details

    NCT Number: NCT04414943
    Other IDs: 2019[336]
    Study URL: https://clinicaltrials.gov/study/NCT04414943
    Last updated: Sep 29, 2023