drugset / Trial / NCT04414943
Low-dose S-ketamine in Women With Prenatal Depression
Completed
364 enrolled
Peking University First Hospital
Hunan Provincial Maternal and Child Health Care Hospital · collabNanjing Medical University · collabPeking University International Hospital · collabWomen's Hospital School Of Medicine Zhejiang University · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2020-06-19
- Primary completion
- 2022-08-03
- Completion
- 2022-08-03
Publications
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- Background Newport DJ, Carpenter LL, McDonald WM, Potash JB, Tohen M, Nemeroff CB; APA Council of Research Task Force on Novel Biomarkers and Treatments. Ketamine and Other NMDA Antagonists: Early Clinical Trials and Possible Mechanisms in Depression. Am J Psychiatry. 2015 Oct;172(10):950-66. doi: 10.1176/appi.ajp.2015.15040465.
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- Background Drewniany E, Han J, Hancock C, Jones RL, Lim J, Nemat Gorgani N, Sperry JK 3rd, Yu HJ, Raffa RB. Rapid-onset antidepressant action of ketamine: potential revolution in understanding and future pharmacologic treatment of depression. J Clin Pharm Ther. 2015 Apr;40(2):125-30. doi: 10.1111/jcpt.12238. Epub 2014 Dec 26.
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- Background Xu Y, Li Y, Huang X, Chen D, She B, Ma D. Single bolus low-dose of ketamine does not prevent postpartum depression: a randomized, double-blind, placebo-controlled, prospective clinical trial. Arch Gynecol Obstet. 2017 May;295(5):1167-1174. doi: 10.1007/s00404-017-4334-8. Epub 2017 Mar 29.
- Background Bartova L, Papageorgiou K, Milenkovic I, Dold M, Weidenauer A, Willeit M, Winkler D, Kasper S. Rapid antidepressant effect of S-ketamine in schizophrenia. Eur Neuropsychopharmacol. 2018 Aug;28(8):980-982. doi: 10.1016/j.euroneuro.2018.05.007. Epub 2018 Jul 2.
- Background 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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- Background Segmiller F, Ruther T, Linhardt A, Padberg F, Berger M, Pogarell O, Moller HJ, Kohler C, Schule C. Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol. 2013 Sep;53(9):996-8. doi: 10.1002/jcph.122. Epub 2013 Jul 24. No abstract available.
- Background Persson J, Hasselstrom J, Maurset A, Oye I, Svensson JO, Almqvist O, Scheinin H, Gustafsson LL, Almqvist O. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol. 2002 Feb;57(12):869-75. doi: 10.1007/s002280100353.
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- Background Gaillard A, Le Strat Y, Mandelbrot L, Keita H, Dubertret C. Predictors of postpartum depression: prospective study of 264 women followed during pregnancy and postpartum. Psychiatry Res. 2014 Feb 28;215(2):341-6. doi: 10.1016/j.psychres.2013.10.003. Epub 2013 Nov 6.
- Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 0.2 mg/kg | Intravenous |