<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/NCT03296956</url>
  </required_header>
  <id_info>
    <org_study_id>083/2015</org_study_id>
    <nct_id>NCT03296956</nct_id>
  </id_info>
  <brief_title>A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial</brief_title>
  <official_title>A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a dietary supplement (DS) is effective in&#xD;
      protecting against sad mood in postpartum as compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This double blind placebo controlled randomized trial will evaluate the effect of&#xD;
      administration of a dietary supplement (DS) on the intensity of postpartum blues. It is&#xD;
      expected that the administration will result in less sadness in day-5 postpartum women after&#xD;
      negative mood induction in those receiving the dietary supplement compared to placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>
    <intervention_model_description>one arm receives Motherwell and one arm receives placebo; randomized double blind The supplement is expected to prevent depressed mood induction during postpartum blues whereas the placebo is not. The effect of depressed mood induction is strong during postpartum blues in 75% to 95% of mothers (who do not take Motherwell). The supplement is the intervention.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>all are blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Visual Analog Scale (VAS)</measure>
    <time_frame>Assessment will be done on day-5 postpartum. On the assessment day, the VAS will be administered before and after sad mood induction and compared]</time_frame>
    <description>VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compare to the change score of the subjects who have received placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States (POMS) Scores</measure>
    <time_frame>Assessment will be done on day-5 postpartum. On the assessment day, the POMS will be administered before and after sad mood induction and compared]</time_frame>
    <description>The POMS contains 65 adjectives rated by participants on a 5-point scale. Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postpartum Blues</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Day-5 postpartum - Active dietary supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum.&#xD;
Intervention: Full dose dietary supplement Motherwell</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day-5 postpartum - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum.&#xD;
Intervention: Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Motherwell</intervention_name>
    <description>The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.</description>
    <arm_group_label>Day-5 postpartum - Active dietary supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo for appearance, taste</description>
    <arm_group_label>Day-5 postpartum - Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 45&#xD;
&#xD;
          -  BMI 19 to 40 (kg/m2)&#xD;
&#xD;
          -  Resting pulse between 45 and 100 bpm&#xD;
&#xD;
          -  Systolic blood pressure between 91 and 139 mmHg (inclusive)&#xD;
&#xD;
          -  Diastolic blood pressure between 51 and 90 mmHg (inclusive)&#xD;
&#xD;
          -  Orthostatic blood pressure change &lt;20 mmHg (based on the difference between supine and&#xD;
             standing (1 minute) systolic blood pressure)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has been diagnosed with any axis 1 and 2 disorders based on Structured&#xD;
             Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders 5 (DSM-5) interview within the past 10 years.&#xD;
&#xD;
          -  Subjects who have been smoking cigarettes in the past 5 years (to reduce variability&#xD;
             in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).&#xD;
&#xD;
          -  Intolerance to any of the components of the intervention.&#xD;
&#xD;
          -  If in the principal investigator's judgement the obstetric or neonatal complications&#xD;
             were so severe that would cause change in the results of the study, such as infant&#xD;
             death, the subject will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey H Meyer, MD,PhD,FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Api Santhirakumar</last_name>
    <phone>416-535-8501</phone>
    <phone_ext>33582</phone_ext>
    <email>postpartum.supplements@camh.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre for Addiciton and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Api Santhirakumar</last_name>
      <phone>416-535-8501</phone>
      <phone_ext>33582</phone_ext>
      <email>postpartum.supplements@camh.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Dowlati Y, Ravindran AV, Segal ZV, Stewart DE, Steiner M, Meyer JH. Selective dietary supplementation in early postpartum is associated with high resilience against depressed mood. Proc Natl Acad Sci U S A. 2017 Mar 28;114(13):3509-3514. doi: 10.1073/pnas.1611965114. Epub 2017 Mar 13.</citation>
    <PMID>28289215</PMID>
  </reference>
  <reference>
    <citation>Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral L-tryptophan or alpha-lactalbumin on total tryptophan levels in breast milk. Eur Neuropsychopharmacol. 2015 Jun;25(6):779-87. doi: 10.1016/j.euroneuro.2015.03.005. Epub 2015 Mar 18.</citation>
    <PMID>25823693</PMID>
  </reference>
  <reference>
    <citation>Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral tyrosine on total tyrosine levels in breast milk: implications for dietary supplementation in early postpartum. Arch Womens Ment Health. 2014 Dec;17(6):541-8. doi: 10.1007/s00737-014-0441-8.</citation>
    <PMID>25015680</PMID>
  </reference>
  <reference>
    <citation>Sacher J, Wilson AA, Houle S, Rusjan P, Hassan S, Bloomfield PM, Stewart DE, Meyer JH. Elevated brain monoamine oxidase A binding in the early postpartum period. Arch Gen Psychiatry. 2010 May;67(5):468-74. doi: 10.1001/archgenpsychiatry.2010.32.</citation>
    <PMID>20439828</PMID>
  </reference>
  <reference>
    <citation>Meyer JH, Wilson AA, Sagrati S, Miler L, Rusjan P, Bloomfield PM, Clark M, Sacher J, Voineskos AN, Houle S. Brain monoamine oxidase A binding in major depressive disorder: relationship to selective serotonin reuptake inhibitor treatment, recovery, and recurrence. Arch Gen Psychiatry. 2009 Dec;66(12):1304-12. doi: 10.1001/archgenpsychiatry.2009.156.</citation>
    <PMID>19996035</PMID>
  </reference>
  <reference>
    <citation>Meyer JH, Ginovart N, Boovariwala A, Sagrati S, Hussey D, Garcia A, Young T, Praschak-Rieder N, Wilson AA, Houle S. Elevated monoamine oxidase a levels in the brain: an explanation for the monoamine imbalance of major depression. Arch Gen Psychiatry. 2006 Nov;63(11):1209-16. doi: 10.1001/archpsyc.63.11.1209.</citation>
    <PMID>17088501</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Jeff Meyer</investigator_full_name>
    <investigator_title>Program Head, Neurochemical Imaging for Mood Disorders</investigator_title>
  </responsible_party>
  <keyword>Postpartum</keyword>
  <keyword>Dietary Supplement</keyword>
  <keyword>Mood Symptoms</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03296956
org study id: 083/2015
nct id: NCT03296956
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether a dietary supplement (DS) is effective in
      protecting against sad mood in postpartum as compared to placebo.
This double blind placebo controlled randomized trial will evaluate the effect of
      administration of a dietary supplement (DS) on the intensity of postpartum blues. It is
      expected that the administration will result in less sadness in day-5 postpartum women after
      negative mood induction in those receiving the dietary supplement compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one arm receives Motherwell and one arm receives placebo; randomized double blind The supplement is expected to prevent depressed mood induction during postpartum blues whereas the placebo is not. The effect of depressed mood induction is strong during postpartum blues in 75% to 95% of mothers (who do not take Motherwell). The supplement is the intervention.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: all are blinded
measure: Change in Visual Analog Scale (VAS)
time frame: Assessment will be done on day-5 postpartum. On the assessment day, the VAS will be administered before and after sad mood induction and compared]
description: VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compare to the change score of the subjects who have received placebo
measure: Change in Profile of Mood States (POMS) Scores
time frame: Assessment will be done on day-5 postpartum. On the assessment day, the POMS will be administered before and after sad mood induction and compared]
description: The POMS contains 65 adjectives rated by participants on a 5-point scale. Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion
arm group label: Day-5 postpartum - Active dietary supplement
arm group type: Active Comparator
description: Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum.
Intervention: Full dose dietary supplement Motherwell
arm group label: Day-5 postpartum - Placebo
arm group type: Placebo Comparator
description: Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum.
Intervention: Placebo
intervention type: Dietary Supplement
intervention name: Motherwell
description: The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.
arm group label: Day-5 postpartum - Active dietary supplement
intervention type: Other
intervention name: Placebo
description: Matching placebo for appearance, taste
arm group label: Day-5 postpartum - Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey H Meyer, MD,PhD,FRCPC
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
last name: Api Santhirakumar
phone: 416-535-8501
phone ext: 33582
email: postpartum.supplements@camh.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Dowlati Y, Ravindran AV, Segal ZV, Stewart DE, Steiner M, Meyer JH. Selective dietary supplementation in early postpartum is associated with high resilience against depressed mood. Proc Natl Acad Sci U S A. 2017 Mar 28;114(13):3509-3514. doi: 10.1073/pnas.1611965114. Epub 2017 Mar 13.
PMID: 28289215
citation: Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral L-tryptophan or alpha-lactalbumin on total tryptophan levels in breast milk. Eur Neuropsychopharmacol. 2015 Jun;25(6):779-87. doi: 10.1016/j.euroneuro.2015.03.005. Epub 2015 Mar 18.
PMID: 25823693
citation: Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral tyrosine on total tyrosine levels in breast milk: implications for dietary supplementation in early postpartum. Arch Womens Ment Health. 2014 Dec;17(6):541-8. doi: 10.1007/s00737-014-0441-8.
PMID: 25015680
citation: Sacher J, Wilson AA, Houle S, Rusjan P, Hassan S, Bloomfield PM, Stewart DE, Meyer JH. Elevated brain monoamine oxidase A binding in the early postpartum period. Arch Gen Psychiatry. 2010 May;67(5):468-74. doi: 10.1001/archgenpsychiatry.2010.32.
PMID: 20439828
citation: Meyer JH, Wilson AA, Sagrati S, Miler L, Rusjan P, Bloomfield PM, Clark M, Sacher J, Voineskos AN, Houle S. Brain monoamine oxidase A binding in major depressive disorder: relationship to selective serotonin reuptake inhibitor treatment, recovery, and recurrence. Arch Gen Psychiatry. 2009 Dec;66(12):1304-12. doi: 10.1001/archgenpsychiatry.2009.156.
PMID: 19996035
citation: Meyer JH, Ginovart N, Boovariwala A, Sagrati S, Hussey D, Garcia A, Young T, Praschak-Rieder N, Wilson AA, Houle S. Elevated monoamine oxidase a levels in the brain: an explanation for the monoamine imbalance of major depression. Arch Gen Psychiatry. 2006 Nov;63(11):1209-16. doi: 10.1001/archpsyc.63.11.1209.
PMID: 17088501
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Jeff Meyer
investigator title: Program Head, Neurochemical Imaging for Mood Disorders
sharing ipd: No