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Clinicaltrials.gov identifier NCT03927378
Recruitment Status Recruiting
First Posted April 25, 2019
Last update posted June 23, 2020
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.
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.
|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.
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
|Placebo Comparator: Placebo group
Placebo (20 ml normal saline) is intravenously infused in 40 minutes after childbirth.
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
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- Parturients with age ≥18 years;
- Presence of prenatal depression (EPDS score ≥10);
- Provide written informed consents.
- 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.
Contact: Dong-Xin Wang, MD, PhD 8610 83572784 firstname.lastname@example.org
Contact: Yuan Zeng, MD 8610 83572460 email@example.com
Peking University First Hospital
Peking University First Hospital
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Kim S, Soeken TA, Cromer SJ, Martinez SR, Hardy LR, Strathearn L. Oxytocin and postpartum depression: delivering on what's known and what's not. Brain Res. 2014 Sep 11;1580:219-32. doi: 10.1016/j.brainres.2013.11.009. Epub 2013 Nov 14. Review.
Giallo R, Pilkington P, McDonald E, Gartland D, Woolhouse H, Brown S. Physical, sexual and social health factors associated with the trajectories of maternal depressive symptoms from pregnancy to 4 years postpartum. Soc Psychiatry Psychiatr Epidemiol. 2017 Jul;52(7):815-828. doi: 10.1007/s00127-017-1387-8. Epub 2017 Apr 27.
Giallo R, Cooklin A, Nicholson JM. Risk factors associated with trajectories of mothers' depressive symptoms across the early parenting period: an Australian population-based longitudinal study. Arch Womens Ment Health. 2014 Apr;17(2):115-25. doi: 10.1007/s00737-014-0411-1. Epub 2014 Jan 15.
Sutter-Dallay AL, Cosnefroy O, Glatigny-Dallay E, Verdoux H, Rascle N. Evolution of perinatal depressive symptoms from pregnancy to two years postpartum in a low-risk sample: the MATQUID cohort. J Affect Disord. 2012 Jun;139(1):23-9. doi: 10.1016/j.jad.2011.08.018. Epub 2012 Mar 11.
McCall-Hosenfeld JS, Phiri K, Schaefer E, Zhu J, Kjerulff K. Trajectories of Depressive Symptoms Throughout the Peri- and Postpartum Period: Results from the First Baby Study. J Womens Health (Larchmt). 2016 Nov;25(11):1112-1121. Epub 2016 Jun 16.
Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-92. doi: 10.1213/ANE.0000000000000107.
Quevedo LA, Silva RA, Godoy R, Jansen K, Matos MB, Tavares Pinheiro KA, Pinheiro RT. The impact of maternal post-partum depression on the language development of children at 12 months. Child Care Health Dev. 2012 May;38(3):420-4. doi: 10.1111/j.1365-2214.2011.01251.x. Epub 2011 Jun 8.
Parsons CE, Young KS, Rochat TJ, Kringelbach ML, Stein A. Postnatal depression and its effects on child development: a review of evidence from low- and middle-income countries. Br Med Bull. 2012;101:57-79. doi: 10.1093/bmb/ldr047. Epub 2011 Nov 29. Review.
Weitzman M, Rosenthal DG, Liu YH. Paternal depressive symptoms and child behavioral or emotional problems in the United States. Pediatrics. 2011 Dec;128(6):1126-34. doi: 10.1542/peds.2010-3034. Epub 2011 Nov 7.
Demontigny F, Girard ME, Lacharité C, Dubeau D, Devault A. Psychosocial factors associated with paternal postnatal depression. J Affect Disord. 2013 Aug 15;150(1):44-9. doi: 10.1016/j.jad.2013.01.048. Epub 2013 Mar 13.
Dietz LJ, Jennings KD, Kelley SA, Marshal M. Maternal depression, paternal psychopathology, and toddlers' behavior problems. J Clin Child Adolesc Psychol. 2009 Jan;38(1):48-61. doi: 10.1080/15374410802575362.
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Jardri R, Pelta J, Maron M, Thomas P, Delion P, Codaccioni X, Goudemand M. Predictive validation study of the Edinburgh Postnatal Depression Scale in the first week after delivery and risk analysis for postnatal depression. J Affect Disord. 2006 Jul;93(1-3):169-76. Epub 2006 Apr 27.
Milgrom J, Gemmill AW, Bilszta JL, Hayes B, Barnett B, Brooks J, Ericksen J, Ellwood D, Buist A. Antenatal risk factors for postnatal depression: a large prospective study. J Affect Disord. 2008 May;108(1-2):147-57. Epub 2007 Dec 18.
Schwartz J, Murrough JW, Iosifescu DV. Ketamine for treatment-resistant depression: recent developments and clinical applications. Evid Based Ment Health. 2016 May;19(2):35-8. doi: 10.1136/eb-2016-102355. Epub 2016 Apr 6. Review.
Abdallah CG, Adams TG, Kelmendi B, Esterlis I, Sanacora G, Krystal JH. KETAMINE'S MECHANISM OF ACTION: A PATH TO RAPID-ACTING ANTIDEPRESSANTS. Depress Anxiety. 2016 Aug;33(8):689-97. doi: 10.1002/da.22501. Epub 2016 Apr 6. Review.
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. Review.
Kishimoto T, Chawla JM, Hagi K, Zarate CA, Kane JM, Bauer M, Correll CU. Single-dose infusion ketamine and non-ketamine N-methyl-d-aspartate receptor antagonists for unipolar and bipolar depression: a meta-analysis of efficacy, safety and time trajectories. Psychol Med. 2016 May;46(7):1459-72. doi: 10.1017/S0033291716000064. Epub 2016 Feb 12.
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.
Strasburger SE, Bhimani PM, Kaabe JH, Krysiak JT, Nanchanatt DL, Nguyen TN, Pough KA, Prince TA, Ramsey NS, Savsani KH, Scandlen L, Cavaretta MJ, Raffa RB. What is the mechanism of Ketamine's rapid-onset antidepressant effect? A concise overview of the surprisingly large number of possibilities. J Clin Pharm Ther. 2017 Apr;42(2):147-154. doi: 10.1111/jcpt.12497. Epub 2017 Jan 22. Review.
Fond G, Loundou A, Rabu C, Macgregor A, Lançon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20. Review.