Development of Dietary Supplements for Mood Symptoms in Postpartum

NCT ID: NCT02073175

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-04-30

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).

Conditions

Postpartum Blues; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Motherwell

Intervention Type: 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 - 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

Group Type: EXPERIMENTAL

Motherwell

Intervention Type: 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 - 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

Group Type: EXPERIMENTAL

Motherwell

Intervention Type: 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 - 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

Group Type: EXPERIMENTAL

Motherwell

Intervention Type: 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

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

Group Type: OTHER

Motherwell

Intervention Type: DRUG

The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.

Interventions

Motherwell

The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Jeff Meyer

Program Head, Neurochemical Imaging for Mood Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey H Meyer, MD,PhD,FRCPC

Role: PRINCIPAL_INVESTIGATOR

Research Imaging Centre, Centre for Addiction and Mental Health

Locations

Centre for Addiciton and Mental Health

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28289215 (View on PubMed)

Related Links

http://camh.ca/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

112/2013

Identifier Type: -

Identifier Source: org_study_id