A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Postpartum Blues
• Intervention / Treatment: Dietary supplement: Motherwell; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Api Santhirakumar; Phone Number: 33582 416-535-8501; Email: postpartum.supplements@camh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiciton and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 to 45
• BMI 19 to 40 (kg/m2)
• Resting pulse between 45 and 100 bpm
• Systolic blood pressure between 91 and 139 mmHg (inclusive)
• Diastolic blood pressure between 51 and 90 mmHg (inclusive)
• Orthostatic blood pressure change <20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)

Exclusion Criteria:

• The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years.
• Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).
• Intolerance to any of the components of the intervention.
• If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Day-5 postpartum - Active dietary supplement; 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	Dietary supplement: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.
Placebo Comparator: Day-5 postpartum - Placebo; 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	Other: Placebo; Matching placebo for appearance, taste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS)	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	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]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Profile of Mood States (POMS) Scores	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	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]

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Jeffrey H Meyer, MD,PhD,FRCPC, Centre for Addiction and Mental Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 25, 2022
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Postpartum; Dietary Supplement; Mood Symptoms
• Other Study ID Numbers: 083/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No