NCT02073175

Development of Dietary Supplements for Mood Symptoms in Postpartum

Completed Phase 2 Last updated 11 April 2016

What this trial tests

Phase 2 trial testing Motherwell in Postpartum Blues in 28 participants. Completed in 1 April 2016.

Timeline

1 February 2014

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Centre for Addiction and Mental Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	28
Start date	1 February 2014
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	1 location across Canada

Drugs / interventions tested

• Motherwell — full drug profile →

Conditions studied

• Postpartum Blues — all drugs for Postpartum Blues →
• Healthy — all drugs for Healthy →

Sponsor

Centre for Addiction and Mental Health — full company profile →

Who can join

Adults 18 to 45, female only, with Postpartum Blues or Healthy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Selective dietary supplementation in early postpartum is associated with high resilience against depressed mood.
   Dowlati Y, Ravindran AV, Segal ZV, Stewart DE, et al · · 2017 · cited 24× · PMID 28289215 · DOI 10.1073/pnas.1611965114