Low-dose S-ketamine in Women With Prenatal Depression

Study Overview
=================
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.

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

Conditions
-----------------
Prenatal Depression, Ketamine, Postpartum Depression

Intervention / Treatment
-----------------
* Drug: S-ketamine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age ≥18 years; Prenatal Edinburgh postnatal depression scale score ≥10 points. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-katamine group<br>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. | Drug: S-ketamine<br>* 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.<br>* Other names: S-ketamine hydrochloride;|
| Placebo Comparator: Placebo group<br>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. | Drug: Placebo<br>* 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.<br>* Other names: Normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 42 days after childbirth. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 7 days after childbirth. | 
| Maternal depression score at 42 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 face-to-face interview or an online video interview. | 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. | 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). | 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. | At 1, 7, and 42 days after childbirth. | 
| Length of hospital stay after giving birth. | Length of hospital stay after giving birth. | Up to 30 days after giving birth. | 
| Incidence of maternal complications within 42 days postpartum. | Maternal complications are defined as those that are harmful to maternal health and require medical intervention. | Up to 42 days after giving birth. | 
| Incidence of neonatal diseases within 42 days. | Neonatal diseases are defined as those that require medical intervention. | Up to 42 days after birth. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prenatal Depression, S-ketamine, Postpartum Depression