Development of Dietary Supplements for Mood Symptoms in P... | NCT02073175

NCT02073175

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Name	Affiliation	Role
Jeffrey H Meyer, MD,PhD,FRCPC	Research Imaging Centre, Centre for Addiction and Mental Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Addiciton and Mental Health		Toronto	Ontario	M5T 1R8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28289215	Derived	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.