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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

Study Description
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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 Intervention/treatment Phase
Perinatal Depression Ketamine Postpartum Depression Drug: S-ketamine Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 19, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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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.
Other Name: S-ketamine hydrochloride
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.
Other Name: Normal saline


Outcome Measures
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927378


Contacts
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Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com
Contact: Yuan Zeng, MD 8610 83572460 yuan_zeng@sina.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    861083572784    wangdongxin@hotmail.com   
Contact: Yuan Zeng, MD    861083572460    yuan_zeng@sina.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
More Information
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Publications:

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03927378    
Other Study ID Numbers: 2018[224]
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Perinatal Depression
S-Ketamine
Postpartum Depression
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Ketamine
Esketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs