Perinatal DepressionPhase 4NCT03336541
Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression
A Phase 4 study testing Ketamine in people with Perinatal Depression and Ketamine, run by Peking University First Hospital at 1 site in China.
Trial summary
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 of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perinatal Depression, Ketamine, Cesarean Delivery
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2017to 25 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturients with age from 18 to 45 years and scheduled for elective cesarean delivery;
- Prenatal depression score (EPDS) of 10 or higher;
- Provide written informed consents.
Who cannot join
- Refused to participate in the study;
- History of schizophrenia or other disease that prevent normal communication before delivery;
- Presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy;
- Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome);
- Severe comorbidity before pregnancy (such as severe cardiac dysfunction);
- Scheduled to undergo cesarean delivery under general anesthesia;
- Other reasons that are considered unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Effects of Intraoperative Low-dose Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression Undergoing Cesarean Delivery: Blind Test, Randomized, Placebo-controlled Trial
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 of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.
Read the detailed description
Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% 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 commonly used as an general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. We hypothesize that low-dose 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 ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.
- Being tested
- Ketamine, Placebo
- Keywords
- Prenatal depression, Ketamine, Cesarean delivery, Postpartum depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine hydrochloride
Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
PlaceboDrug
Also called Normal saline
Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Experimental | Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. Receives: Drug: Ketamine |
| Placebo group | Placebo comparator | Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of postpartum depression at 48 hous after childbirth.
Postpartum depression is assessed with Edinburgh postnatal depression scale (EPDS) at 48 hours after childbirth. The EPDS is a 10-item self-rating post-natal depression scale. Each item is scored from 0 to 3, resulting an overall score ranging from 0-30; a high score indicates severe depression.
Measured: At 48 hours after delivery.
Secondary outcomes (8)
Time of first breast feeding.
Time of first breast feeding.
Measured: From delivery to 24 hours after delivery.
The proportion of neonates with breast feeding.
The proportion of neonates with breast feeding.
Measured: At 24 hours after delivery.
Duration of neonatal sleep within 24 hours after delivery.
Duration of neonatal sleep within 24 hours after delivery.
Measured: During the first 24 hours after delivery.
Length of stay in hospital after delivery.
Length of stay in hospital after delivery.
Measured: From childbirth up to 30 days after delivery.
The score of postpartum depression at 42 days after delivery.
Postpartum depression is assessed with EPDS at 42 days after childbirth.
Measured: At 42 days after delivery.
Incidence of postpartum depression at 42 days after delivery.
Postpartum depression is assessed with EPDS at 42 days after childbirth. A EPDS score of 10 or above is defined as postpartum depression.
Measured: At 42 days after delivery.
Incidence of maternal complications with 42 days after delivery.
Incidence of maternal complications with 42 days after delivery.
Measured: From childbirth up to 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.
Measured: From childbirth up to 42 days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start23 Nov 2017
- Primary completion14 May 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336541
- Sponsor's protocol ID
- 2017[36]
- Status last verified
- Dec 2021
- First submitted
- 6 Nov 2017
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel M, Bailey RK, Jabeen S, Ali S, Barker NC, Osiezagha K. Postpartum depression: a review. J Health Care Poor Underserved. 2012 May;23(2):534-42. doi: 10.1353/hpu.2012.0037.
PubMed 22643605Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
PubMed 25455250Verbeek T, Bockting CL, van Pampus MG, Ormel J, Meijer JL, Hartman CA, Burger H. Postpartum depression predicts offspring mental health problems in adolescence independently of parental lifetime psychopathology. J Affect Disord. 2012 Feb;136(3):948-54. doi: 10.1016/j.jad.2011.08.035. Epub 2011 Sep 17.
PubMed 21930302Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
PubMed 19625979Kersten-Alvarez LE, Hosman CM, Riksen-Walraven JM, van Doesum KT, Smeekens S, Hoefnagels C. Early school outcomes for children of postpartum depressed mothers: comparison with a community sample. Child Psychiatry Hum Dev. 2012 Apr;43(2):201-18. doi: 10.1007/s10578-011-0257-y.
PubMed 22011810Raposa E, Hammen C, Brennan P, Najman J. The long-term effects of maternal depression: early childhood physical health as a pathway to offspring depression. J Adolesc Health. 2014 Jan;54(1):88-93. doi: 10.1016/j.jadohealth.2013.07.038. Epub 2013 Sep 20.
PubMed 24060574Naicker K, Wickham M, Colman I. Timing of first exposure to maternal depression and adolescent emotional disorder in a national Canadian cohort. PLoS One. 2012;7(3):e33422. doi: 10.1371/journal.pone.0033422. Epub 2012 Mar 26.
PubMed 22461893Schiller CE, Meltzer-Brody S, Rubinow DR. The role of reproductive hormones in postpartum depression. CNS Spectr. 2015 Feb;20(1):48-59. doi: 10.1017/S1092852914000480. Epub 2014 Sep 29.
PubMed 25263255Hart AR, Farber KG, Kellner ChH. Postpartum Depression. N Engl J Med. 2017 Mar 2;376(9):895. doi: 10.1056/NEJMc1616547. No abstract available.
PubMed 28252268Kingston D, McDonald S, Austin MP, Tough S. Association between Prenatal and Postnatal Psychological Distress and Toddler Cognitive Development: A Systematic Review. PLoS One. 2015 May 21;10(5):e0126929. doi: 10.1371/journal.pone.0126929. eCollection 2015.
PubMed 25996151Layer RT, Popik P, Olds T, Skolnick P. Antidepressant-like actions of the polyamine site NMDA antagonist, eliprodil (SL-82.0715). Pharmacol Biochem Behav. 1995 Nov;52(3):621-7. doi: 10.1016/0091-3057(95)00155-p.
PubMed 8545484Meloni D, Gambarana C, De Montis MG, Dal Pra P, Taddei I, Tagliamonte A. Dizocilpine antagonizes the effect of chronic imipramine on learned helplessness in rats. Pharmacol Biochem Behav. 1993 Oct;46(2):423-6. doi: 10.1016/0091-3057(93)90374-3.
PubMed 7903459Moryl E, Danysz W, Quack G. Potential antidepressive properties of amantadine, memantine and bifemelane. Pharmacol Toxicol. 1993 Jun;72(6):394-7. doi: 10.1111/j.1600-0773.1993.tb01351.x.
PubMed 8361950Papp M, Moryl E. Antidepressant activity of non-competitive and competitive NMDA receptor antagonists in a chronic mild stress model of depression. Eur J Pharmacol. 1994 Sep 22;263(1-2):1-7. doi: 10.1016/0014-2999(94)90516-9.
PubMed 7821340Przegalinski E, Tatarczynska E, Deren-Wesolek A, Chojnacka-Wojcik E. Antidepressant-like effects of a partial agonist at strychnine-insensitive glycine receptors and a competitive NMDA receptor antagonist. Neuropharmacology. 1997 Jan;36(1):31-7. doi: 10.1016/s0028-3908(96)00157-8.
PubMed 9144639
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Low-dose Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression Undergoing Cesarean Delivery: Blind Test, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03336541
- Acronym / sponsor ID
- 2017[36]
- Keywords
- Prenatal depression, Ketamine, Cesarean delivery, Postpartum depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.
Detailed description
Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% 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 commonly used as an general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. We hypothesize that low-dose 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 ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Experimental | Drug: KetamineLow-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parturients with age from 18 to 45 years and scheduled for elective cesarean delivery;
- Prenatal depression score (EPDS) of 10 or higher;
- Provide written informed consents.
Key exclusion criteria (7 listed)
- Refused to participate in the study;
- History of schizophrenia or other disease that prevent normal communication before delivery;
- Presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy;
- Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome);
- Severe comorbidity before pregnancy (such as severe cardiac dysfunction);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketamine hydrochlorideKetamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery. | Drug | Ketamine group |
| PlaceboAlso: Normal salinePlacebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery. | Drug | Placebo group |
Primary outcome
The score of postpartum depression at 48 hous after childbirth.
Time frame: At 48 hours after delivery.
Postpartum depression is assessed with Edinburgh postnatal depression scale (EPDS) at 48 hours after childbirth. The EPDS is a 10-item self-rating post-natal depression scale. Each item is scored from 0 to 3, resulting an overall score ranging from 0-30; a high score indicates severe depression.
8 secondary outcomes
Time of first breast feeding.
Time frame: From delivery to 24 hours after delivery.
The proportion of neonates with breast feeding.
Time frame: At 24 hours after delivery.
Duration of neonatal sleep within 24 hours after delivery.
Time frame: During the first 24 hours after delivery.
Length of stay in hospital after delivery.
Time frame: From childbirth up to 30 days after delivery.
The score of postpartum depression at 42 days after delivery.
Time frame: At 42 days after delivery.
Incidence of postpartum depression at 42 days after delivery.
Time frame: At 42 days after delivery.
Incidence of maternal complications with 42 days after delivery.
Time frame: From childbirth up to 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.
Time frame: From childbirth up to 42 days after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Background: PubMed 22643605Patel M, Bailey RK, Jabeen S, Ali S, Barker NC, Osiezagha K. Postpartum depression: a review. J Health Care Poor Underserved. 2012 May;23(2):534-42. doi: 10.1353/hpu.2012.0037.
- Background: PubMed 25455250Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
- Background: PubMed 21930302Verbeek T, Bockting CL, van Pampus MG, Ormel J, Meijer JL, Hartman CA, Burger H. Postpartum depression predicts offspring mental health problems in adolescence independently of parental lifetime psychopathology. J Affect Disord. 2012 Feb;136(3):948-54. doi: 10.1016/j.jad.2011.08.035. Epub 2011 Sep 17.
- Background: PubMed 19625979Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
- Background: PubMed 22011810Kersten-Alvarez LE, Hosman CM, Riksen-Walraven JM, van Doesum KT, Smeekens S, Hoefnagels C. Early school outcomes for children of postpartum depressed mothers: comparison with a community sample. Child Psychiatry Hum Dev. 2012 Apr;43(2):201-18. doi: 10.1007/s10578-011-0257-y.
- Background: PubMed 24060574Raposa E, Hammen C, Brennan P, Najman J. The long-term effects of maternal depression: early childhood physical health as a pathway to offspring depression. J Adolesc Health. 2014 Jan;54(1):88-93. doi: 10.1016/j.jadohealth.2013.07.038. Epub 2013 Sep 20.
- Background: PubMed 22461893Naicker K, Wickham M, Colman I. Timing of first exposure to maternal depression and adolescent emotional disorder in a national Canadian cohort. PLoS One. 2012;7(3):e33422. doi: 10.1371/journal.pone.0033422. Epub 2012 Mar 26.
- Background: PubMed 25263255Schiller CE, Meltzer-Brody S, Rubinow DR. The role of reproductive hormones in postpartum depression. CNS Spectr. 2015 Feb;20(1):48-59. doi: 10.1017/S1092852914000480. Epub 2014 Sep 29.
- Background: PubMed 28252268Hart AR, Farber KG, Kellner ChH. Postpartum Depression. N Engl J Med. 2017 Mar 2;376(9):895. doi: 10.1056/NEJMc1616547. No abstract available.
- Background: PubMed 25996151Kingston D, McDonald S, Austin MP, Tough S. Association between Prenatal and Postnatal Psychological Distress and Toddler Cognitive Development: A Systematic Review. PLoS One. 2015 May 21;10(5):e0126929. doi: 10.1371/journal.pone.0126929. eCollection 2015.
- Background: PubMed 8545484Layer RT, Popik P, Olds T, Skolnick P. Antidepressant-like actions of the polyamine site NMDA antagonist, eliprodil (SL-82.0715). Pharmacol Biochem Behav. 1995 Nov;52(3):621-7. doi: 10.1016/0091-3057(95)00155-p.
- Background: PubMed 7903459Meloni D, Gambarana C, De Montis MG, Dal Pra P, Taddei I, Tagliamonte A. Dizocilpine antagonizes the effect of chronic imipramine on learned helplessness in rats. Pharmacol Biochem Behav. 1993 Oct;46(2):423-6. doi: 10.1016/0091-3057(93)90374-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Perinatal Depression and Ketamine, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of postpartum depression at 48 hous after childbirth. (time frame: At 48 hours after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336541, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.