Low-dose S-ketamine in Women With Prenatal Depression

Peking University First Hospital364 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

364

Conditions

Prenatal Depression Ketamine Postpartum Depression

Interventions

S-ketamineDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

The incidence of depression at 42 days postpartum.

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

Time frame: At 42 days after childbirth.

Secondary Outcomes

Maternal depression score at 7 days postpartum.

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.

Time frame: At 7 days after childbirth.

Maternal depression score at 42 days postpartum.

Time frame: At 42 days after childbirth.

Maternal depression severity at 42 days postpartum.

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.

Time frame: At 42 days after childbirth.

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

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

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

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

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

Data from ClinicalTrials.gov

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