<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04414943</url>
  </required_header>
  <id_info>
    <org_study_id>2019[336]</org_study_id>
    <nct_id>NCT04414943</nct_id>
  </id_info>
  <brief_title>Low-dose S-ketamine in Women With Prenatal Depression</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Provincial Maternal and Child Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Women's Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Women's Hospital School Of Medicine Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine&#xD;
      has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar&#xD;
      effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal&#xD;
      depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of&#xD;
      postpartum depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that prenatal depression symptoms are important predictors of postpartum&#xD;
      depression. Screening of pregnant women's mental condition before giving birth, early&#xD;
      identification of pregnant women with symptoms of prenatal depression, and providing&#xD;
      appropriate interventions may play an important role in reducing the incidence of postpartum&#xD;
      depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed&#xD;
      that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine,&#xD;
      s-ketamine has similar effects to ketamine in anti-depression. In clinical application,&#xD;
      s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of&#xD;
      adverse psychological reactions. We speculate that, for pregnant women with prenatal&#xD;
      depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression.&#xD;
      Evidence is lacking in this regard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">August 3, 2022</completion_date>
  <primary_completion_date type="Actual">August 3, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of depression at 42 days postpartum.</measure>
    <time_frame>At 42 days after childbirth.</time_frame>
    <description>Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal depression score at 7 days postpartum.</measure>
    <time_frame>At 7 days after childbirth.</time_frame>
    <description>Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal depression score at 42 days postpartum.</measure>
    <time_frame>At 42 days after childbirth.</time_frame>
    <description>Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal depression severity at 42 days postpartum.</measure>
    <time_frame>At 42 days after childbirth.</time_frame>
    <description>Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain at 1, 7, and 42 days postpartum.</measure>
    <time_frame>At 1, 7, and 42 days after childbirth.</time_frame>
    <description>Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal breast feeding at 1, 7, and 42 days postpartum.</measure>
    <time_frame>At 1, 7, and 42 days after childbirth.</time_frame>
    <description>The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay after giving birth.</measure>
    <time_frame>Up to 30 days after giving birth.</time_frame>
    <description>Length of hospital stay after giving birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of maternal complications within 42 days postpartum.</measure>
    <time_frame>Up to 42 days after giving birth.</time_frame>
    <description>Maternal complications are defined as those that are harmful to maternal health and require medical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of neonatal diseases within 42 days.</measure>
    <time_frame>Up to 42 days after birth.</time_frame>
    <description>Neonatal diseases are defined as those that require medical intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Prenatal Depression</condition>
  <condition>Ketamine</condition>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>S-katamine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-ketamine</intervention_name>
    <description>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.</description>
    <arm_group_label>S-katamine group</arm_group_label>
    <other_name>S-ketamine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Maternal age ≥18 years;&#xD;
&#xD;
          2. Prenatal Edinburgh postnatal depression scale score ≥10 points.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A clear history of mental illness (depression, schizophrenia, etc.) or communication&#xD;
             difficulties;&#xD;
&#xD;
          2. Severe pregnancy complications, such as severe preeclampsia, placental implantation,&#xD;
             HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count)&#xD;
             syndrom, placenta previa, and placental abruption;&#xD;
&#xD;
          3. American Society of Anesthesiologists classification ≥III;&#xD;
&#xD;
          4. Presence of contraindications to ketamine/s-ketamine use, such as refractory&#xD;
             hypertension, severe cardiovascular disease (New York Heart Association classification&#xD;
             ≥III), and hyperthyroidism.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This clinical trail is based in pregnant women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong-Xin Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Provincial Maternal and Child Health Care Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huaian Maternal and Child Health Care Hospital</name>
      <address>
        <city>Huaian</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Maternal and Child Health Care Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Hospital School Of Medicine Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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    <citation>Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.</citation>
    <PMID>26707087</PMID>
  </reference>
  <reference>
    <citation>Paul R, Schaaff N, Padberg F, Moller HJ, Frodl T. Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases. World J Biol Psychiatry. 2009;10(3):241-4. doi: 10.1080/15622970701714370.</citation>
    <PMID>19224412</PMID>
  </reference>
  <reference>
    <citation>Gaillard A, Le Strat Y, Mandelbrot L, Keita H, Dubertret C. Predictors of postpartum depression: prospective study of 264 women followed during pregnancy and postpartum. Psychiatry Res. 2014 Feb 28;215(2):341-6. doi: 10.1016/j.psychres.2013.10.003. Epub 2013 Nov 6.</citation>
    <PMID>24370337</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 1, 2023</last_update_submitted>
  <last_update_submitted_qc>April 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Xin Wang</investigator_full_name>
    <investigator_title>Professor and Chairman, Department of Anesthesiology and Critical Care Medicine</investigator_title>
  </responsible_party>
  <keyword>Prenatal Depression</keyword>
  <keyword>S-ketamine</keyword>
  <keyword>Postpartum Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Esketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04414943
org study id: 2019[336]
nct id: NCT04414943
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of depression at 42 days postpartum.
time frame: At 42 days after childbirth.
description: Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
measure: Maternal depression score at 7 days postpartum.
time frame: At 7 days after childbirth.
description: Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
measure: Maternal depression score at 42 days postpartum.
time frame: At 42 days after childbirth.
description: Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
measure: Maternal depression severity at 42 days postpartum.
time frame: At 42 days after childbirth.
description: Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
measure: Intensity of pain at 1, 7, and 42 days postpartum.
time frame: At 1, 7, and 42 days after childbirth.
description: Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
measure: Maternal breast feeding at 1, 7, and 42 days postpartum.
time frame: At 1, 7, and 42 days after childbirth.
description: The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
measure: Length of hospital stay after giving birth.
time frame: Up to 30 days after giving birth.
description: Length of hospital stay after giving birth.
measure: Incidence of maternal complications within 42 days postpartum.
time frame: Up to 42 days after giving birth.
description: Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
measure: Incidence of neonatal diseases within 42 days.
time frame: Up to 42 days after birth.
description: Neonatal diseases are defined as those that require medical intervention.
arm group label: S-katamine group
arm group type: Experimental
description: 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.
arm group label: Placebo group
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: S-ketamine
description: 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.
arm group label: S-katamine group
other name: S-ketamine hydrochloride
intervention type: Drug
intervention name: Placebo
description: 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.
arm group label: Placebo group
other name: Normal saline
criteria: 
gender: Female
gender based: Yes
gender description: This clinical trail is based in pregnant women.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dong-Xin Wang, MD, PhD
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
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PMID: 26707087
citation: Paul R, Schaaff N, Padberg F, Moller HJ, Frodl T. Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases. World J Biol Psychiatry. 2009;10(3):241-4. doi: 10.1080/15622970701714370.
PMID: 19224412
citation: Gaillard A, Le Strat Y, Mandelbrot L, Keita H, Dubertret C. Predictors of postpartum depression: prospective study of 264 women followed during pregnancy and postpartum. Psychiatry Res. 2014 Feb 28;215(2):341-6. doi: 10.1016/j.psychres.2013.10.003. Epub 2013 Nov 6.
PMID: 24370337
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Dong-Xin Wang
investigator title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Ketamine
mesh term: Esketamine
sharing ipd: No
ipd description: IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.