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OpenTrials
Completed

NCT Number: NCT02073175

Development of Dietary Supplements for Mood Symptoms in Postpartum

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

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Key information

Conditions

Postpartum Blues Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Addiciton and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motherwell

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2014
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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