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

Sponsor

Peking University First Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03927378

Collaborator

(none)

364

Enrollment

Location

Arms

25.4

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. Parturients with prenatal depression are at increased risk of postpartum depression. Low-dose s-ketamine can be used for antidepressant therapy. We hypothesize that low-dose s-ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose s-ketamine administered after childbirth can reduce the incidence of postpartum depression in parturients with prenatal depression.

Condition or Disease	Intervention/Treatment	Phase
Perinatal Depression Ketamine Postpartum Depression	Drug: S-ketamine Drug: Placebo	N/A

Detailed Description

Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 10% to 20%. The development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. Prenatal depression or high depression score is an independent risk factor for the development of postpartum depression.

Ketamine is a commonly used general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. S-ketamine is more potent as an anaesthetic and might also have a better antidepressive effect. We hypothesize that low-dose s-ketamine has a therapeutic effect on parturients with prenatal depression. However, evidences in this aspect are insufficient. The purpose of this study is to investigate whether low-dose s-ketamine administered after childbirth can reduce the incidence of postpartum depression in parturients with prenatal depression.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

364 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 19, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-katamine group Low-dose s-ketamine (0.2 mg/kg in 20 ml normal saline) is intravenously infused in 40 minutes after childbirth.	Drug: S-ketamine S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. Other Names: S-ketamine hydrochloride
Placebo Comparator: Placebo group Placebo (20 ml normal saline) is intravenously infused in 40 minutes after childbirth.	Drug: Placebo Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. Other Names: Normal saline

Arm

Intervention/Treatment

Experimental: S-katamine group

Low-dose s-ketamine (0.2 mg/kg in 20 ml normal saline) is intravenously infused in 40 minutes after childbirth.

Drug: S-ketamine

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

Other Names:

S-ketamine hydrochloride

Placebo Comparator: Placebo group

Placebo (20 ml normal saline) is intravenously infused in 40 minutes after childbirth.

Drug: Placebo

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

Other Names:

Normal saline

Outcome Measures

Primary Outcome Measures

The incidence of depression at 42 days after childbirth. [At 42 days after childbirth.]
Postpartum depression at 42 days is diagnosed by using the Mini-International Neuropsychiatric Interview-Version 6.0 (MINI-V6.0) by a psychiatrist.

Secondary Outcome Measures

The score of depression at 7 and 42 days after childbirth. [At 7 and 42 days after childbirth.]
The score of depression at 7 and 42 days after childbirth is assessed by using the Edinburgh Postpartum Depression Scale (EPDS). This is a 10-item self-report questionnaire; each item is rated from 0 to 3 denoting the increasing severity of symptoms, resulting in a total score range from 0 to 30, with higher score indicating more severe depression.
The score of pain at 1, 7 and 42 days after childbirth. [At 1, 7 and 42 days after childbirth.]
The score of pain at 1, 7 and 42 days after childbirth is assessed by using a Numeric Rating Scale (an 11-point scale where 0 indicates no pain and 10 the worst pain).
The proportion of neonates with breast-feeding. [At 1, 7 and 42 days after childbirth.]
The proportion of neonates with breast-feeding.
The incidence of postpartum complications within 42 days after childbirth. [Up to 42 days after childbirth.]
The incidence of postpartum complications within 42 days after childbirth.
The incidence of neonatal disease within 42 days after birth. [Up to 42 days after childbirth.]
The incidence of neonatal disease within 42 days after birth.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Parturients with age ≥18 years;
Presence of prenatal depression (EPDS score ≥10);
Provide written informed consents.

Exclusion Criteria:

History of psychiatric disease (schizophrenia) or communication barriers that prevent normal communication before childbirth;
Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, or HELLP [Hemolysis, Elevated Liver enzymes and Low Platelets] syndrome);
ASA physical status classification ≥III;
Presence of contraindications to ketamine, including refractory hypertension, severe cardiovascular disease (heart function classification ≥III), or hyperthyroidism;
Refuse to participate.