Development of Dietary Supplements for Mood Symptoms in Postpartum

Phase 2

Completed

• Conditions: Postpartum Blues; Healthy
• Interventions: Drug: Motherwell

• Registration Number: NCT02073175
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postpartum with crying spells-Full dose	Motherwell	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
Day-5 postpartum - Full dose	Motherwell	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
Day-5 postpartum - Half dose	Motherwell	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
Day-5 postpartum - Quarter dose	Motherwell	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
Day-5 postpartum - Control	Motherwell	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

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS)	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	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

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Centre for Addiciton and Mental Health; 🇨🇦 Toronto, Ontario, Canada