Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low-dose S-ketamine in Women With Prenatal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414943
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Prenatal Depression Ketamine Postpartum Depression Drug: S-ketamine Drug: Placebo Not Applicable

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.

Layout table for study information
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 the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S-katamine group
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.
Drug: S-ketamine
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.
Other Name: S-ketamine hydrochloride

Placebo Comparator: Placebo group
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.
Drug: Placebo
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.
Other Name: Normal saline




Primary Outcome Measures :
  1. The incidence of depression at 42 days postpartum. [ Time Frame: At 42 days after childbirth. ]
    Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.


Secondary Outcome Measures :
  1. Maternal depression scores at 7 and 42 days postpartum. [ Time Frame: At 7 and 42 days after childbirth. ]
    Maternal depression will be assessed with the Edinburgh postnatal depression scale (EPDS). The assessment will be conducted by a telephone interview or a face-to-face interview.

  2. Intensity of pain at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).

  3. Maternal breast feeding at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.

  4. Length of hospital stay after giving birth. [ Time Frame: Up to 30 days after giving birth. ]
    Length of hospital stay after giving birth.

  5. Incidence of maternal complications within 42 days postpartum. [ Time Frame: Up to 42 days after giving birth. ]
    Maternal complications are defined as those that are harmful to maternal health and require medical intervention.

  6. Incidence of neonatal diseases within 42 days. [ Time Frame: Up to 42 days after birth. ]
    Neonatal diseases are defined as those that require medical intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This clinical trail is based in pregnant women.
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04414943


Contacts
Layout table for location contacts
Contact: Dong-Xin Wang, MD,PHD 8610 83572784 wangdongxin@hotmail.com
Contact: Yuan Zeng, MD 8610 83572460 yuan_zeng@sina.com

Locations
Layout table for location information
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PHD    8610-83572784    wangdongxin@hotmail.com   
Contact: Yuan Zeng, MD    8610-83572460    yuan_zeng@sina.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications of Results:

Layout table for additonal information
Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04414943    
Other Study ID Numbers: 2019[336]
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.

Layout table for additional information
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:
Prenatal Depression
S-ketamine
Postpartum Depression
Additional relevant MeSH terms:
Layout table for MeSH terms
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