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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03927378

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted June 23, 2020

Study Description

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.

  • Condition or Disease:Ketamine
    Perinatal Depression
    Postpartum Depression
  • Intervention/Treatment: Drug: S-ketamine
    Drug: Placebo
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 364 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
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.
Drug: S-ketamine
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.
Drug: Placebo
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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).
  • 3. The proportion of neonates with breast-feeding. [ Time Frame: At 1, 7 and 42 days after childbirth. ]
    The proportion of neonates with breast-feeding.
  • 4. 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.
  • 5. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com

Contact: Yuan Zeng, MD 8610 83572460 yuan_zeng@sina.com

Locations

China, Beijing
Peking University First Hospital
Beijing

Sponsors and Collaborators

Peking University First Hospital

Investigators

Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

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