Postpartum BluesNCT03296956
A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial
A study testing Motherwell in people with Postpartum Blues and Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Blues, Healthy
- What is being tested?
- Motherwell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45
- 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)
- Orthostatic blood pressure change <20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)
Who cannot join
- The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years.
- Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).
- Intolerance to any of the components of the intervention.
- If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Postpartum Blues, Healthy
- Being tested
- Motherwell, Placebo
- Keywords
- Postpartum, Dietary Supplement, Mood Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotherwellDietary supplement
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.
PlaceboOther
Matching placebo for appearance, taste
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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]
Secondary outcomes (1)
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
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Dec 2018
- Primary completion25 Dec 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum BluesStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Meyer, Centre for Addiction and Mental Health
- Investigators
- Jeffrey H Meyer, MD,PhD,FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296956
- Sponsor's protocol ID
- 083/2015
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2017
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28289215Dowlati 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.
PubMed 25823693Dowlati 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.
PubMed 25015680Sacher 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.
PubMed 20439828Meyer 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.
PubMed 19996035Meyer 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.
PubMed 17088501Meyer 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.
PubMed 38813444
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03296956
- Acronym / sponsor ID
- 083/2015
- Conditions
- Postpartum Blues, Healthy
- Keywords
- Postpartum, Dietary Supplement, Mood Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Day-5 postpartum - Active dietary supplement | Active comparator | Dietary Supplement: MotherwellHealthy 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 | Other: PlaceboHealthy 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 45
- 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)
Key exclusion criteria (4 listed)
- The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years.
- Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).
- Intolerance to any of the components of the intervention.
- If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotherwellThe interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women. | Dietary supplement | Day-5 postpartum - Active dietary supplement |
| PlaceboMatching placebo for appearance, taste | Other | Day-5 postpartum - Placebo |
Primary outcome
Change in Visual Analog Scale (VAS)
Time frame: 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]
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
1 secondary outcome
Change in Profile of Mood States (POMS) Scores
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 28289215Dowlati 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.
- Background: PubMed 25823693Dowlati 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.
- Background: PubMed 25015680Dowlati 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.
- Background: PubMed 20439828Sacher 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.
- Background: PubMed 19996035Meyer 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.
- Background: PubMed 17088501Meyer 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.
- Derived from this study: PubMed 38813444Meyer 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.
- Individual participant dataSharing planned: No
Related trials for Postpartum Blues
Recruiting
Investigation of TVNS Administration on Postpartum Mental Health
Postpartum Depression (PPD), Postpartum Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Meyer, MD,PhD,FRCPC principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motherwell in people with Postpartum Blues and Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) (time frame: 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296956, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.