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Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression

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ClinicalTrials.gov Identifier: NCT03927378
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE June 19, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
The incidence of depression at 42 days after childbirth. [ Time Frame: At 42 days after childbirth. ]
Postpartum depression at 42 days is diagnosed by using the Mini-International Neuropsychiatric Interview-Version 6.0 (MINI-V6.0) by a psychiatrist.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
The incidence of depression at 42 days after childbirth. [ Time Frame: At 42 days after childbirth. ]
Postpartum depression at 42 days is diagnosed by using the Mini-International Neuropsychiatric Interview-Version 6.0, MINI-V6.0) by a psychiatrist.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • The score of depression at 7 and 42 days after childbirth. [ Time Frame: At 7 and 42 days after childbirth. ]
    The score of depression at 7 and 42 days after childbirth is assessed by using the Edinburgh Postpartum Depression Scale (EPDS). This is a 10-item self-report questionnaire; each item is rated from 0 to 3 denoting the increasing severity of symptoms, resulting in a total score range from 0 to 30, with higher score indicating more severe depression.
  • The score of pain at 1, 7 and 42 days after childbirth. [ Time Frame: At 1, 7 and 42 days after childbirth. ]
    The score of pain at 1, 7 and 42 days after childbirth is assessed by using a Numeric Rating Scale (an 11-point scale where 0 indicates no pain and 10 the worst pain).
  • The proportion of neonates with breast-feeding. [ Time Frame: At 1, 7 and 42 days after childbirth. ]
    The proportion of neonates with breast-feeding.
  • The incidence of postpartum complications within 42 days after childbirth. [ Time Frame: Up to 42 days after childbirth. ]
    The incidence of postpartum complications within 42 days after childbirth.
  • The incidence of neonatal disease within 42 days after birth. [ Time Frame: Up to 42 days after childbirth. ]
    The incidence of neonatal disease within 42 days after birth.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • The score of depression at 7 and 42 days after childbirth. [ Time Frame: At 7 and 42 days after childbirth. ]
    The score of depression at 7 and 42 days after childbirth is assessed by using the Edinburgh Postpartum Depression Scale (EPDS).
  • The score of pain at 1, 7 and 42 days after childbirth. [ Time Frame: At 1, 7 and 42 days after childbirth. ]
    The score of pain at 1, 7 and 42 days after childbirth is assessed by using a Numeric Rating Scale (an 11-point scale where 0 indicates no pain and 10 the worst pain).
  • The proportion of neonates with breast-feeding. [ Time Frame: At 1, 7 and 42 days after childbirth. ]
    The proportion of neonates with breast-feeding.
  • The incidence of postpartum complications within 42 days after childbirth. [ Time Frame: Up to 42 days after childbirth. ]
    The incidence of postpartum complications within 42 days after childbirth.
  • The incidence of neonatal disease within 42 days after birth. [ Time Frame: Up to 42 days after childbirth. ]
    The incidence of neonatal disease within 42 days after birth.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
Official Title  ICMJE Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
Brief 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 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Perinatal Depression
  • Ketamine
  • Postpartum Depression
Intervention  ICMJE
  • Drug: S-ketamine
    S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
    Other Name: S-ketamine hydrochloride
  • Drug: Placebo
    Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
    Other Name: Normal saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: S-ketamine
  • Placebo Comparator: Placebo group
    Placebo (20 ml normal saline) is intravenously infused in 40 minutes after childbirth.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
364
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parturients with age ≥18 years;
  • Presence of prenatal depression (EPDS score ≥10);
  • Provide written informed consents.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com
Contact: Yuan Zeng, MD 8610 83572460 yuan_zeng@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927378
Other Study ID Numbers  ICMJE 2018[224]
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dong-Xin Wang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP