Effect of Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth
- Conditions
- Postpartum DepressionPrenatal DepressionKetamine
- Interventions
- Drug: Placebo
- Registration Number
- NCT05698394
- Lead Sponsor
- Peking University First Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 364
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Placebo 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. Esketamine group Esketamine For women in this group, study drug (esketamine 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.
- Primary Outcome Measures
Name Time Method Incidence maternal depression at 3 years postpartum At 3 years postpartum (33-41 months) Incidence of depression in women at 3 years postpartum. Diagnosis was made according to M.I.N.I. 6.0.
- Secondary Outcome Measures
Name Time Method PHQ-9 scores and incidence of moderate-severe depression in women at 3 years postpartum. At 3 years postpartum (33-41 months) PHQ-9 score and moderate-severe depression (PHQ-9 score ≥10) in women at 3 years postpartum.
Incidence of chronic pain in women at 3 years postpartum At 3 years postpartum (33-41 months) Incidence of chronic pain in women at 3 years postpartum
Incidence of developmental delay in offspring at 3 years of age At 3 years postpartum (33-41 months) Incidence of developmental delay in offspring at 3 years of age measured by the Ages \& Stages Questionnaires 3rd edition (ASQ-3) in Chinese
Trial Locations
- Locations (4)
Women's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Hunan Provincial Maternal and Child Health Care Hospital
🇨🇳Changsha, Hunan, China
Women's Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Peking University First Hospital
🇨🇳Beijing, China