Development of Dietary Supplements for Mood Symptoms in Postpartum

Phase 2CompletedNCT02073175

Centre for Addiction and Mental Health28 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postpartum Blues Healthy

Interventions

MotherwellDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Addiciton and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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