Development of Dietary Supplements for Mood Symptoms in Postpartum

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum.

Study Overview

• Status: Completed
• Conditions: Healthy; Postpartum Blues
• Intervention / Treatment: Drug: Motherwell

Detailed Description

The specific aim of this open-label study is to assess whether the proposed dietary supplement can reduce the intensity of sadness in women vulnerable to sadness (day-5 postpartum women and women within the first 18 months postpartum with crying spells).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

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: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18 to 45
• The subject, as reported by them, should be in a good health.
• The subject is not taking any medication.
• The subject is not taking any investigational medicinal product within 8 weeks.
• 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)

Exclusion Criteria:

• The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for DSM-IV interview.
• Substance abuse disorder
• Subjects who have been smoking in the past 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postpartum with crying spells-Full dose; Healthy women who are within the first 18 months postpartum and have crying spells but do not have major depression. The effect of the dietary supplement in reducing sadness in this group will be assessed. Intervention: Full dose dietary supplement Motherwell	Drug: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
Experimental: Day-5 postpartum - Full dose; 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	Drug: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
Experimental: Day-5 postpartum - Half dose; Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Half dose dietary supplement Motherwell	Drug: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
Experimental: Day-5 postpartum - Quarter dose; Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Quarter dose dietary supplement Motherwell	Drug: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
Other: Day-5 postpartum - Control; Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving a control supplement consumption, is being done after delivery and during postpartum. Intervention: Control protein to compare with Motherwell	Drug: Motherwell; The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.

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 not received any supplement and have been recently recruited	Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution 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 or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared

Collaborators and Investigators

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

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Postpartum; Dietary Supplements; Mood Symptoms
• Other Study ID Numbers: 112/2013

Plan for Individual participant data (IPD)

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