search
Back to results

Low-dose S-ketamine in Women With Prenatal Depression

Primary Purpose

Prenatal Depression, Ketamine, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
S-ketamine
Placebo
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prenatal Depression focused on measuring Prenatal Depression, S-ketamine, Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Maternal age ≥18 years;
  2. Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria:

  1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
  2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
  3. American Society of Anesthesiologists classification ≥III;
  4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.

Sites / Locations

  • Peking University First Hospital
  • Beijing Tiantan Hospital
  • Peking University International Hospital
  • Hunan Provincial Maternal and Child Health Care Hospital
  • Huaian Maternal and Child Health Care Hospital
  • Nanjing Maternal and Child Health Care Hospital
  • Women's Hospital School Of Medicine Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-katamine group

Placebo group

Arm Description

For women in this group, study drug (s-ketamine 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. Women will be monitored for 60 minutes and then sent back to the ward.

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. Women will be monitored for 60 minutes and then sent back to the ward.

Outcomes

Primary Outcome Measures

The incidence of depression at 42 days postpartum.
Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.

Secondary Outcome Measures

Maternal depression score at 7 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
Maternal depression score at 42 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Maternal depression severity at 42 days postpartum.
Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Intensity of pain at 1, 7, and 42 days postpartum.
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Maternal breast feeding at 1, 7, and 42 days postpartum.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Length of hospital stay after giving birth.
Length of hospital stay after giving birth.
Incidence of maternal complications within 42 days postpartum.
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Incidence of neonatal diseases within 42 days.
Neonatal diseases are defined as those that require medical intervention.

Full Information

First Posted
June 1, 2020
Last Updated
April 1, 2023
Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT04414943
Brief Title
Low-dose S-ketamine in Women With Prenatal Depression
Official Title
Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prenatal Depression, Ketamine, Postpartum Depression
Keywords
Prenatal Depression, S-ketamine, Postpartum Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-katamine group
Arm Type
Experimental
Arm Description
For women in this group, study drug (s-ketamine 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. Women will be monitored for 60 minutes and then sent back to the ward.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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. Women will be monitored for 60 minutes and then sent back to the ward.
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Other Intervention Name(s)
S-ketamine hydrochloride
Intervention Description
For women in this group, active drug (s-ketamine 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. They will be monitored for 60 minutes and then sent back to the ward.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
Primary Outcome Measure Information:
Title
The incidence of depression at 42 days postpartum.
Description
Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
Time Frame
At 42 days after childbirth.
Secondary Outcome Measure Information:
Title
Maternal depression score at 7 days postpartum.
Description
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
Time Frame
At 7 days after childbirth.
Title
Maternal depression score at 42 days postpartum.
Description
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Time Frame
At 42 days after childbirth.
Title
Maternal depression severity at 42 days postpartum.
Description
Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Time Frame
At 42 days after childbirth.
Title
Intensity of pain at 1, 7, and 42 days postpartum.
Description
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Time Frame
At 1, 7, and 42 days after childbirth.
Title
Maternal breast feeding at 1, 7, and 42 days postpartum.
Description
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Time Frame
At 1, 7, and 42 days after childbirth.
Title
Length of hospital stay after giving birth.
Description
Length of hospital stay after giving birth.
Time Frame
Up to 30 days after giving birth.
Title
Incidence of maternal complications within 42 days postpartum.
Description
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Time Frame
Up to 42 days after giving birth.
Title
Incidence of neonatal diseases within 42 days.
Description
Neonatal diseases are defined as those that require medical intervention.
Time Frame
Up to 42 days after birth.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This clinical trail is based in pregnant women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maternal age ≥18 years; Prenatal Edinburgh postnatal depression scale score ≥10 points. Exclusion Criteria: A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties; Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption; American Society of Anesthesiologists classification ≥III; Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University International Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Hunan Provincial Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Huaian Maternal and Child Health Care Hospital
City
Huaian
State/Province
Jiangsu
Country
China
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.
Citations:
PubMed Identifier
9559758
Citation
Nonacs R, Cohen LS. Postpartum mood disorders: diagnosis and treatment guidelines. J Clin Psychiatry. 1998;59 Suppl 2:34-40.
Results Reference
background
PubMed Identifier
24239932
Citation
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.
Results Reference
background
PubMed Identifier
28451700
Citation
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.
Results Reference
background
PubMed Identifier
24424796
Citation
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.
Results Reference
background
PubMed Identifier
22410506
Citation
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.
Results Reference
background
PubMed Identifier
27310295
Citation
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. doi: 10.1089/jwh.2015.5310. Epub 2016 Jun 16.
Results Reference
background
PubMed Identifier
20654759
Citation
Tsai R, Schaffir J. Effect of depot medroxyprogesterone acetate on postpartum depression. Contraception. 2010 Aug;82(2):174-7. doi: 10.1016/j.contraception.2010.03.004. Epub 2010 Apr 13.
Results Reference
background
PubMed Identifier
24797120
Citation
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):383-392. doi: 10.1213/ANE.0000000000000107.
Results Reference
background
PubMed Identifier
21651606
Citation
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.
Results Reference
background
PubMed Identifier
22130907
Citation
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.
Results Reference
background
PubMed Identifier
22065273
Citation
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.
Results Reference
background
PubMed Identifier
23489392
Citation
Demontigny F, Girard ME, Lacharite 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.
Results Reference
background
PubMed Identifier
19130357
Citation
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.
Results Reference
background
PubMed Identifier
17854906
Citation
Pawlby S, Sharp D, Hay D, O'Keane V. Postnatal depression and child outcome at 11 years: the importance of accurate diagnosis. J Affect Disord. 2008 Apr;107(1-3):241-5. doi: 10.1016/j.jad.2007.08.002. Epub 2007 Sep 12.
Results Reference
background
PubMed Identifier
15234824
Citation
Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
Results Reference
background
PubMed Identifier
19327773
Citation
Klainin P, Arthur DG. Postpartum depression in Asian cultures: a literature review. Int J Nurs Stud. 2009 Oct;46(10):1355-73. doi: 10.1016/j.ijnurstu.2009.02.012. Epub 2009 Mar 26.
Results Reference
background
PubMed Identifier
18818022
Citation
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.
Results Reference
background
PubMed Identifier
11177155
Citation
Lee DT, Yip AS, Leung TY, Chung TK. Identifying women at risk of postnatal depression: prospective longitudinal study. Hong Kong Med J. 2000 Dec;6(4):349-54.
Results Reference
background
PubMed Identifier
18067974
Citation
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. doi: 10.1016/j.jad.2007.10.014. Epub 2007 Dec 18.
Results Reference
background
PubMed Identifier
22436053
Citation
Siu BW, Leung SS, Ip P, Hung SF, O'Hara MW. Antenatal risk factors for postnatal depression: a prospective study of Chinese women at maternal and child health centres. BMC Psychiatry. 2012 Mar 22;12:22. doi: 10.1186/1471-244X-12-22.
Results Reference
background
PubMed Identifier
18458732
Citation
Huynh NN, McIntyre RS. What Are the Implications of the STAR*D Trial for Primary Care? A Review and Synthesis. Prim Care Companion J Clin Psychiatry. 2008;10(2):91-6. doi: 10.4088/pcc.v10n0201.
Results Reference
background
PubMed Identifier
27053196
Citation
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.
Results Reference
background
PubMed Identifier
10686270
Citation
Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
Results Reference
background
PubMed Identifier
26423481
Citation
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.
Results Reference
background
PubMed Identifier
26867988
Citation
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.
Results Reference
background
PubMed Identifier
25545040
Citation
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.
Results Reference
background
PubMed Identifier
28111761
Citation
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.
Results Reference
background
PubMed Identifier
25038867
Citation
Fond G, Loundou A, Rabu C, Macgregor A, Lancon 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.
Results Reference
background
PubMed Identifier
26824031
Citation
Park M, Niciu MJ, Zarate CA Jr. Novel Glutamatergic Treatments for Severe Mood Disorders. Curr Behav Neurosci Rep. 2015 Dec;2(4):198-208. doi: 10.1007/s40473-015-0050-5. Epub 2015 Oct 9.
Results Reference
background
PubMed Identifier
17458544
Citation
Perry EB Jr, Cramer JA, Cho HS, Petrakis IL, Karper LP, Genovese A, O'Donnell E, Krystal JH, D'Souza DC; Yale Ketamine Study Group. Psychiatric safety of ketamine in psychopharmacology research. Psychopharmacology (Berl). 2007 Jun;192(2):253-60. doi: 10.1007/s00213-007-0706-2. Epub 2007 Feb 16.
Results Reference
background
PubMed Identifier
28357557
Citation
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.
Results Reference
background
PubMed Identifier
30041987
Citation
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.
Results Reference
background
PubMed Identifier
29736744
Citation
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.
Results Reference
background
PubMed Identifier
29656663
Citation
Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Am J Psychiatry. 2018 Jul 1;175(7):620-630. doi: 10.1176/appi.ajp.2018.17060720. Epub 2018 Apr 16.
Results Reference
background
PubMed Identifier
23893490
Citation
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.
Results Reference
background
PubMed Identifier
11936706
Citation
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.
Results Reference
background
PubMed Identifier
26707087
Citation
Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.
Results Reference
background
PubMed Identifier
19224412
Citation
Paul R, Schaaff N, Padberg F, Moller HJ, Frodl T. Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases. World J Biol Psychiatry. 2009;10(3):241-4. doi: 10.1080/15622970701714370.
Results Reference
background
PubMed Identifier
24370337
Citation
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.
Results Reference
background

Learn more about this trial

Low-dose S-ketamine in Women With Prenatal Depression

We'll reach out to this number within 24 hrs