Clinical trial NCT04414943: Low-dose S-ketamine in Women With Prenatal Depression
Official title: Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Depression
Ketamine
Postpartum Depression
Keywords: Prenatal Depression
S-ketamine
Postpartum Depression
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Nanjing Medical University
name: Women's Hospital School Of Medicine Zhejiang University
First posted: 2020-06-04
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:
measure: The incidence of depression at 42 days postpartum.
timeFrame: At 42 days after childbirth.
Secondary outcomes:
measure: Maternal depression score at 7 days postpartum.
timeFrame: At 7 days after childbirth.
measure: Maternal depression score at 42 days postpartum.
timeFrame: At 42 days after childbirth.
measure: Maternal depression severity at 42 days postpartum.
timeFrame: At 42 days after childbirth.
measure: Intensity of pain at 1, 7, and 42 days postpartum.
timeFrame: At 1, 7, and 42 days after childbirth.
measure: Maternal breast feeding at 1, 7, and 42 days postpartum.
timeFrame: At 1, 7, and 42 days after childbirth.
measure: Length of hospital stay after giving birth.
timeFrame: Up to 30 days after giving birth.
measure: Incidence of maternal complications within 42 days postpartum.
timeFrame: Up to 42 days after giving birth.
measure: Incidence of neonatal diseases within 42 days.
timeFrame: Up to 42 days after birth.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Huaian
country: China
facility: Huaian Maternal and Child Health Care Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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