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The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum as compared to placebo.
This double blind placebo controlled randomized trial will evaluate the effect of administration of a dietary supplement (DS) on the intensity of postpartum blues. It is expected that the administration will result in less sadness in day-5 postpartum women after negative mood induction in those receiving the dietary supplement compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day-5 postpartum - Active dietary supplement | Active Comparator | 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 - Placebo | Placebo Comparator | 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: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motherwell | Dietary Supplement | The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women. |
|
| 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 received placebo | Assessment will be done on day-5 postpartum. On the assessment day, the VAS will be administered before and after sad mood induction and compared] |
| 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. On the assessment day, the POMS will be administered before and after sad mood induction and compared] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey H Meyer, MD,PhD,FRCPC | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28289215 | Background | 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. | |
| 25823693 | Background |
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one arm receives Motherwell and one arm receives placebo; randomized double blind The supplement is expected to prevent depressed mood induction during postpartum blues whereas the placebo is not. The effect of depressed mood induction is strong during postpartum blues in 75% to 95% of mothers (who do not take Motherwell). The supplement is the intervention.
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all are blinded
| Placebo | Other | Matching placebo for appearance, taste |
|
| Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral L-tryptophan or alpha-lactalbumin on total tryptophan levels in breast milk. Eur Neuropsychopharmacol. 2015 Jun;25(6):779-87. doi: 10.1016/j.euroneuro.2015.03.005. Epub 2015 Mar 18. |
| 25015680 | Background | Dowlati Y, Ravindran AV, Maheux M, Steiner M, Stewart DE, Meyer JH. No effect of oral tyrosine on total tyrosine levels in breast milk: implications for dietary supplementation in early postpartum. Arch Womens Ment Health. 2014 Dec;17(6):541-8. doi: 10.1007/s00737-014-0441-8. |
| 20439828 | Background | Sacher J, Wilson AA, Houle S, Rusjan P, Hassan S, Bloomfield PM, Stewart DE, Meyer JH. Elevated brain monoamine oxidase A binding in the early postpartum period. Arch Gen Psychiatry. 2010 May;67(5):468-74. doi: 10.1001/archgenpsychiatry.2010.32. |
| 19996035 | Background | Meyer JH, Wilson AA, Sagrati S, Miler L, Rusjan P, Bloomfield PM, Clark M, Sacher J, Voineskos AN, Houle S. Brain monoamine oxidase A binding in major depressive disorder: relationship to selective serotonin reuptake inhibitor treatment, recovery, and recurrence. Arch Gen Psychiatry. 2009 Dec;66(12):1304-12. doi: 10.1001/archgenpsychiatry.2009.156. |
| 17088501 | Background | Meyer JH, Ginovart N, Boovariwala A, Sagrati S, Hussey D, Garcia A, Young T, Praschak-Rieder N, Wilson AA, Houle S. Elevated monoamine oxidase a levels in the brain: an explanation for the monoamine imbalance of major depression. Arch Gen Psychiatry. 2006 Nov;63(11):1209-16. doi: 10.1001/archpsyc.63.11.1209. |
| 38813444 | Derived | Meyer JH, Wang Z, Santhirakumar A, Dowlati Y, Docteur N, Shoaib A, Purnava J, Wang Y, Wang W, Chen S, Husain MI, de Silva Wijeyeratne R, Reeyaz H, Baena-Tan C, Koshimori Y, Nasser Z, Sit V. Dietary supplement for mood symptoms in early postpartum: a double-blind randomized placebo controlled trial. EClinicalMedicine. 2024 Apr 10;71:102593. doi: 10.1016/j.eclinm.2024.102593. eCollection 2024 May. |