Development of Dietary Supplements for Mood Symptoms in Postpartum

Center for Addiction and Mental Health (CAMH)

Status and phase: Completed; Phase 2

Conditions: Healthy; Postpartum Blues

Treatments: Drug: Motherwell

Study type: Interventional

Funder types: Other

Identifiers

NCT02073175

112/2013

Details and patient eligibility

About

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum.

Full 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).

Enrollment: 28 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 5 patient groups

Postpartum with crying spells-Full dose

Experimental group

Description:

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

Treatment:

Drug: Motherwell

Day-5 postpartum - Full dose

Experimental group

Description:

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

Treatment:

Drug: Motherwell

Day-5 postpartum - Half dose

Experimental group

Description:

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

Treatment:

Drug: Motherwell

Day-5 postpartum - Quarter dose

Experimental group

Description:

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

Treatment:

Drug: Motherwell

Day-5 postpartum - Control

Other group

Description:

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

Treatment:

Drug: Motherwell