Development of Dietary Supplements for Mood Symptoms in Postpartum

Healthy Clinical Trial

Official title:

Development of Dietary Supplements for Mood Symptoms in Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073175
• Other study ID #: 112/2013
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2014
• Last updated: April 11, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Postpartum Blues

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Addiciton and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	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 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	No

External Links

•   Information about research at the Centre for Addiction and Mental Health