Development of Dietary Supplements for Mood Symptoms in Postpartum

NCT02073175 | Completed Phase 2

• 1 other identifier: 112/2013
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Blues; Healthy

Keywords

Postpartum; Dietary Supplements; Mood Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Profile of Mood States (POMS) Scores

  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

Study Arms (5)

Postpartum with crying spells-Full dose

EXPERIMENTAL

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

Day-5 postpartum - Full dose

EXPERIMENTAL

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

Day-5 postpartum - Half dose

EXPERIMENTAL

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

Day-5 postpartum - Quarter dose

EXPERIMENTAL

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

Day-5 postpartum - Control

OTHER

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

Interventions

Motherwell DRUG

The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.

Day-5 postpartum - Control; Day-5 postpartum - Full dose; Day-5 postpartum - Half dose; Day-5 postpartum - Quarter dose; Postpartum with crying spells-Full dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiciton and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

• 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 DERIVED

Related Links

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

Study Officials

• Jeffrey H Meyer, MD,PhD,FRCPC

  Research Imaging Centre, Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Head, Neurochemical Imaging for Mood Disorders

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)