Effect of Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth
NCT ID: NCT05698394
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
364 participants
INTERVENTIONAL
2023-09-09
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Esketamine group
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.
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 group
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.
Placebo
20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prenatal Edinburgh postnatal depression scale score ≥10 points.
Exclusion Criteria
* 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).
18 Years
FEMALE
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
MD, PHD, Professor and Chairman
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
Women's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, , China
Countries
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References
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McIntyre RS, Rosenblat JD, Nemeroff CB, Sanacora G, Murrough JW, Berk M, Brietzke E, Dodd S, Gorwood P, Ho R, Iosifescu DV, Lopez Jaramillo C, Kasper S, Kratiuk K, Lee JG, Lee Y, Lui LMW, Mansur RB, Papakostas GI, Subramaniapillai M, Thase M, Vieta E, Young AH, Zarate CA Jr, Stahl S. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021 May 1;178(5):383-399. doi: 10.1176/appi.ajp.2020.20081251. Epub 2021 Mar 17.
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Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
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Other Identifiers
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2022-562
Identifier Type: -
Identifier Source: org_study_id