Development of Dietary Supplements for Mood Symptoms in Postpartum
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in Visual Analog Scale (VAS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Motherwell (Drug)
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
Intervention: Motherwell (Drug)
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
Intervention: Motherwell (Drug)
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
Intervention: Motherwell (Drug)
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
Intervention: Motherwell (Drug)
Outcomes
Primary Outcomes
Change in Visual Analog Scale (VAS)
Time Frame: 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 Outcomes
- 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)
Investigators
Jeff Meyer
Program Head, Neurochemical Imaging for Mood Disorders
Centre for Addiction and Mental Health