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. 2024 Apr 10:71:102593.
doi: 10.1016/j.eclinm.2024.102593. eCollection 2024 May.

Dietary supplement for mood symptoms in early postpartum: a double-blind randomized placebo controlled trial

Jeffrey H Meyer  1   2 , ZhaoHui Wang  1   2 , Apitharani Santhirakumar  1   2 , Yekta Dowlati  1   2 , Natalia Docteur  1   2 , Aqsa Shoaib  1   2 , Jareeat Purnava  1   2 , Yanqi Wang  1   2 , Wei Wang  1   2 , Sheng Chen  1   2 , Muhammad I Husain  1   2 , Rashmi de Silva Wijeyeratne  1   2 , Heba Reeyaz  1   2 , Catalina Baena-Tan  1   2 , Yuko Koshimori  1   2 , Zahra Nasser  1   2 , Valery Sit  1   2
Affiliations

Dietary supplement for mood symptoms in early postpartum: a double-blind randomized placebo controlled trial

Jeffrey H Meyer et al. EClinicalMedicine. .

Abstract

Background: Postpartum blues (PPB) is a frequent syndrome of sad mood, crying spells, anxiety, restlessness, reduced appetite, and irritability, typically peaking day 5 postpartum. When severe, it greatly increases risk for later postpartum depression. This trial compared a dietary supplement to placebo on PPB severity. The supplement was designed to counter downstream effects of elevated monoamine oxidase A level, implicated in causing PPB.

Methods: Participants recruited by advertisement from the Toronto region completed procedures at CAMH, Canada and/or participants' homes. Oral supplement or identical appearing relatively inert placebo were administered in randomised, double-blind fashion. Supplement was blueberry juice and extract given four times between nighttime day 3 and morning day 5 postpartum; tryptophan 2 g nighttime day 4 postpartum, and tyrosine 10 g morning day 5 postpartum. On day 5, depressed mood induction procedure (MIP) and postpartum blues were assessed. All data is presented (NCT03296956 closed, clinicaltrials.gov).

Findings: Between January 2019 and December 2022, participants took supplement (n = 51) or placebo (n = 52). There was no significant effect on primary outcome MIP on visual analogue scale for depressed mood (mean difference = -0.39 mm, 95% CI: -6.42 to 5.65 mm). Stein Maternity Blues scores, exploratory PPB measure, was lower in the active group (effect size 0.62; median, interquartile range (IQR): active 2.00 (IQR 1, 4); placebo 4.00 (IQR 1.5, 6); regression with general linear model, supplement effect, β coefficient = -1.50 (95%: CI -2.60, -0.40), p = 0.008; effect of CES-D crying category before supplement, p = 0.03-0.00000023). Twenty-six and 40 different adverse events occurred within 25% and 42% of supplement and placebo cases respectively (Chi-Square, p = 0.06).

Interpretation: The primary outcome was negative for effect on depressed mood induction, however the supplement moderately reduced PPB.

Funding: CAMH/Exeltis.

Keywords: Antioxidants; Postpartum blues; Postpartum depression; Tryptophan; Tyrosine.

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Conflict of interest statement

JHM is the inventor on patents for the dietary supplement and there is an agreement between CAMH and Exeltis for the latter to manufacture, and distribute the dietary supplement. JHM also has patents for blood biomarkers in mood disorders to predict neuroinflammation, elevated MAO-B level and elevated MAO-A level in the brain. JHM has received operating grant funding from Exeltis and Sanofi in the past 2 years. MIH receives research grants from the Canadian Institutes of Health Research, CAMH Foundation, University of Toronto, COMPASS Pathfinder; stipend from Society of Biological Psychiatry; payment or honoraria from the American Society of Clinical Psychopharmacology and American College Health Association; consulting fees from Wake Network Inc. and stock options in Mindset Pharma Inc.

Figures

Fig. 1
Fig. 1
Trial profile: a Randomization took place before giving birth in order to deliver supplement prior to giving birth. b Postpartum blues typically peaks/is present at day 5. c 52 started supplement but one had a rash and did not complete assessments. 52 participants who started taking the supplement had data to include in record of adverse events and 51 participants who completed taking the supplement had data to include in intent to treat analysis.
Fig. 2
Fig. 2
Timeline of key measures in peripartum: CES-D, Center for Epidemiologic Studies Depression Scale (applied to describe days −2 to day 4). VAS, Visual Analogue Scales; POMS, Profile of Mood States.
Fig. 3
Fig. 3
No effect of mood induction procedure on visual analogue scale for depressed mood: VAS, Visual Analogue Scale for Depressed Mood (in mm). Change in VAS shown is mean of third and fourth VAS minus mean of first and second VAS. Error bars represent standard deviation. No significant effect of treatment on change in VAS (mixed effects model, p = 0.90), CI (−6.42, 5.65).
Fig. 4
Fig. 4
Depressive symptoms over first 6 months postpartum: CES-D, Center for Epidemiologic Studies Depression Scale. Interaction between changes in CES-D over time favoured active supplement (interaction between treatment and time, mixed effects model, p = 0.05; alternatively piecewise regression, p = 0.01). Vertical lines represent standard error.
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