Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

Postpartum Depression Clinical Trial

Official title:

Effect of Intravenous Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth in Women With Prenatal Depression: 2-year Follow-up of a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05698394
• Other study ID #: 2022-562
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 19, 2020
• Est. completion date: November 2024

Study information

• Verified date: January 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postpartum depression refers to the depression after childbirth, which is a common mental disorder in women. The pathogenesis of postpartum depression is not fully understood, and may be related to a variety of factors. Prenatal depression is an important risk factor for postpartum depression. Our recent multicenter randomized controlled trial, "Effect of Low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous infusion of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The preliminary results showed that it reduced the incidence of postpartum depression at 42 days. Since there were no studies on the effect of intravenous esketamine infusion after delivery on long-term postpartum depression, this study is a long-term follow-up of the previous randomized trial. We aim to explore the effect of low-dose intravenous esketamine after delivery on the incidence of 2-year maternal depression after delivery in women with prenatal depressive symptoms.

Description:

Postpartum depression refers to the depression after childbirth. It is a common mental disorder after childbirth. In recent years, it has attracted more and more public attention. Studies have reported an incidence of postpartum depression ranging from 10% to 29%. Our previous findings showed that the incidence of depression at 42 days postpartum was 24.3%. Postpartum depression has adverse effects on physical and mental health of women, but also may have adverse influences on offspring including nutrition health, and cognitive and behavioral development. The pathogenesis of postpartum depression is not completely clear, and may be related to many factors, such as hormone level changes after childbirth, psychosocial factors, and adverse obstetric factors. Plently of studies have shown that prenatal depression is an important risk factor for postpartum depression. One meta-analysis showed that the incidence of postnatal depression could be as high as 39% in people with prenatal depression. Therefore, it is possible to reduce the occurrence of postpartum depression by active intervention of prenatal depressed parturients. Ketamine, an NMDA-receptor antagonist, is a classic analgesic drug with advantages of light respiratory and circulatory inhibition and good analgesic effect. Recently, it has been found to have antidepressant effect and has been widely used in the field of psychiatry. Esketamine, a S-enantiomer of racemic ketamine, has similar antidepressant effects to equivalent doses of ketamine, with a lower incidence of adverse reactions. In 2019, esketamine was approved by the US FDA for the treatment of treatment-resistant depression. At present, the results of studies on the use of esketamine in the perioperative period for the prevention and treatment of postoperative or postpartum depression are mixed. Our recent multicenter randomized controlled trial, "Effect of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous administration of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The multicenter study included 364 women who were given a low dose of esketamine intravenously after delivery. Preliminary results show that it can reduce the incidence of postpartum depression at 42 days. Here we conduct a 2-year follow-up of the women enrolled in the underlying trial to figure out the occurrence of 2-year maternal depression, and to explore the effect of immediate intravenous infusion of low-dose esketamine on the incidence of chronic depression at 2 years postpartum.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 364
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

All 364 pregnant women who participated in the underling trial "Effect of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression: a randomized, double-blind, placebo-controlled trial" NCT04414943)and agreed to accept this 2-year follow-up.

The inclusion criteria of the underlying trial:

• Maternal age =18 years;
• Prenatal Edinburgh postnatal depression scale score =10 points.

Exclusion Criteria of the previous study:

• A clear history of mental illness (depression, schizophrenia, etc.) or communication disorders
• Severe pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placenta abruption) before surgery;
• ASA grade =III;
• The presence of contraindications to ketamine/esketamine use (e.g., stubborn, refractory hypertension, severe cardiovascular disease [cardiac function grade =III], hyperthyroidism).

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Ketamine
• Postpartum Depression
• Prenatal Depression

Intervention

Drug:
• Esketamine
0.2 mg/kg S-ketamine in 20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth
• Placebo
20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	Women's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Women's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence maternal depression at 2 years postpartum	Incidence of depression in women at 2 years postpartum. Diagnosis was made according to M.I.N.I. 6.0.	At 2 years postpartum (24-30 months)
Secondary	PHQ-9 scores and incidence of moderate-severe depression in women at 2 years postpartum.	PHQ-9 score and moderate-severe depression (PHQ-9 score =10) in women at 2 years postpartum.	At 2 years postpartum (24-30 months)
Secondary	Incidence of chronic pain in women at 2 years postpartum	Incidence of chronic pain in women at 2 years postpartum	At 2 years postpartum (24-30 months)
Secondary	Incidence of developmental delay in offspring at 2 years of age	Incidence of developmental delay in offspring at 2 years of age measured by the Ages & Stages Questionnaires 3rd edition (ASQ-3) in Chinese	At 2 years postpartum (24-30 months)