Postpartum BluesPhase 2NCT02073175
Development of Dietary Supplements for Mood Symptoms in Postpartum
A Phase 2 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Blues, Healthy
- What is being tested?
- Motherwell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Apr 2016
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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.
Read the 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).
- Conditions
- Postpartum Blues, Healthy
- Being tested
- Motherwell
- Keywords
- Postpartum, Dietary Supplements, Mood Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotherwellDrug
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Motherwell |
| Day-5 postpartum - Control | Other | 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 Receives: Drug: Motherwell |
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 not received any supplement and have been recently recruited
Measured: 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 (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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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, Research Imaging Centre, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073175
- Sponsor's protocol ID
- 112/2013
- Status last verified
- Apr 2016
- First submitted
- 21 Feb 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- 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 28289215
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Dietary Supplements for Mood Symptoms in Postpartum
- ClinicalTrials.gov ID
- NCT02073175
- Acronym / sponsor ID
- 112/2013
- Conditions
- Postpartum Blues, Healthy
- Keywords
- Postpartum, Dietary Supplements, Mood Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Feb 2014 (estimated)
- 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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Postpartum with crying spells-Full dose | Experimental | Drug: MotherwellHealthy 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 | Experimental | Drug: 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 - Half dose | Experimental | Drug: MotherwellHealthy 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 | Experimental | Drug: MotherwellHealthy 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 | Other | Drug: MotherwellHealthy 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
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 women vulnerable to sadness. | Drug | Day-5 postpartum - Control, Day-5 postpartum - Full dose, Day-5 postpartum - Half dose, Day-5 postpartum - Quarter dose, Postpartum with crying spells-Full dose |
Primary outcome
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
1 secondary outcome
Change in Profile of Mood States (POMS) Scores
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 POMS will be administered before and after sad mood indcution 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 13 Apr 2016.
- Derived from this study: 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.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- 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
Research Imaging Centre, 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 Phase 2 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 8 inclusion and 3 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 13 Apr 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 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). 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 NCT02073175, which also lists 1 linked publication.
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 13 Apr 2016.