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

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03296956
Collaborator
(none)
100
1
2
52.9
1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Motherwell
  • Other: Placebo
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
all are blinded
Primary Purpose:
Other
Official Title:
A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial
Actual Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Visual Analog Scale (VAS) [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]]

    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

Secondary Outcome Measures

  1. Change in Profile of Mood States (POMS) Scores [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]]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Addiciton and Mental Health Toronto Ontario Canada M5T 1R8

Sponsors and Collaborators

  • Centre for Addiction and Mental Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jeff Meyer, Program Head, Neurochemical Imaging for Mood Disorders, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT03296956
Other Study ID Numbers:
  • 083/2015
First Posted:
Sep 29, 2017
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jeff Meyer, Program Head, Neurochemical Imaging for Mood Disorders, Centre for Addiction and Mental Health

Study Results

No Results Posted as of Jun 3, 2022