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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03927378

Enrollment

364

Registered

2019-04-25

Start date

2020-06-19

Completion date

2022-08-03

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketamine, Postpartum Depression, Prenatal Depression

Keywords

Prenatal Depression, S-Ketamine, Postpartum Depression

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.

Detailed description

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.

Interventions

DRUGS-ketamine

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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) 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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of depression at 42 days after childbirth.	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

Measure	Time frame	Description
Maternal depression score at 42 days postpartum.	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.
Maternal depression severity at 42 days postpartum.	At 42 days after childbirth.	Maternal depression severity will be assessed with the Hamilton Depression Scale-17
Intensity of pain at 1, 7, and 42 days postpartum.	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).
Maternal depression score at 7 days postpartum.	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.
Length of hospital stay after giving birth.	Up to 30 days after giving birth.	Length of hospital stay after giving birth.
Incidence of maternal complications within 42 days postpartum.	Up to 42 days after giving birth.	Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Incidence of neonatal diseases within 42 days.	Up to 42 days after birth.	Neonatal diseases are defined as those that require medical intervention.
Maternal breast feeding at 1, 7, and 42 days postpartum.	At 1, 7, and 42 days after childbirth.	The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026