Evidence map›Paper›PMID 31584571›Full record

ArticleDrugs of today (Barcelona, Spain : 1998)2019

Brexanolone for the treatment of patients with postpartum depression.

K E Morrison, A B Cole, S M Thompson, T L Bale

Open access · greenAbstract read
In one paragraph

Article in Drugs of today (Barcelona, Spain : 1998), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
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  10. PTSD as an Endothelial Disease: Insights From COVID-19.Frontiers in cellular neuroscience · 2021
    Review
  11. Review
  12. Pubertal adversity alters chromatin dynamics and stress circuitry in the pregnant brain.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2020
    Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

K E MorrisonDepartments of Pharmacology and Psychiatry and Center for Epigenetic Research in Child Health and Brain Development, University of Maryland School of Medicine, Baltimore, Maryland, USA.
A B ColeDepartment of Physiology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
S M ThompsonDepartment of Physiology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
T L BaleDepartments of Pharmacology and Psychiatry and Center for Epigenetic Research in Child Health and Brain Development, University of Maryland School of Medicine, Baltimore, Maryland, USA. tbale@som.umaryland.edu.
University of Maryland, Baltimore · US

Funding

Paternal stress epigenetic programming of offspring neurodevelopmentR37MH108286 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI BALE, TRACY L · 2015 to 2024
$6.2M
Stress, Depression, Serotonin, and Plasticity of Excitatory TransmissionR01MH086828 · NIMH · UNIVERSITY OF MARYLAND BALTIMORE · PI THOMPSON, SCOTT M. · 2010 to 2019
$3.8M
Placental epigenetic mechanisms contributing to sex-specific impacts of maternal stress on fetal developmentR01HD097093 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI BALE, TRACY L · 2019 to 2023
$2.4M
Female preconception stress programming of offspring neurodevelopmentR01ES028202 · NIEHS · UNIVERSITY OF MARYLAND BALTIMORE · PI BALE, TRACY L · 2017 to 2021
$2.2M
Role of hormonal state in programming effects of peripubertal stress in femalesR00HD091376 · NICHD · WEST VIRGINIA UNIVERSITY · PI MORRISON, KATHLEEN ELIZABETH · 2020 to 2022
$578k
Maternal stress and the vaginal microbiome: impacts on brain developmentR21MH104184 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI BALE, TRACY L · 2014 to 2015
$555k
Role of hormonal state in programming effects of peripubertal stress in femalesK99HD091376 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI MORRISON, KATHLEEN ELIZABETH · 2017 to 2018
$251k
NICHD NIH HHS K99 HD091376NICHD NIH HHS R00 HD091376NICHD NIH HHS R01 HD097093NIEHS NIH HHS R01 ES028202NIMH NIH HHS R01 MH086828NIMH NIH HHS R21 MH104184NIMH NIH HHS R37 MH108286
6 · The paper itself

Abstract

On March 19, 2019, the United States Food and Drug Administration (FDA) approved Zulresso (brexanolone) for intravenous use for the treatment of postpartum depression (PPD) in adult women. The decision was based on three recent clinical trials following an FDA priority review and breakthrough therapy designation. Brexanolone is now available through a restricted process called the Zulresso Risk Evaluation and Mitigation Strategy Program that requires the drug to be administered by a healthcare provider in a certified healthcare facility. Brexanolone represents an important new treatment option to address treatment-resistant depressive symptoms. In this article, we discuss the current critical need for PPD treatments, the mechanisms of brexanolone action, and the efficacy and drug safety studies that led to FDA approval. Additionally, we discuss some limitations of the current formulation, specific populations of women that might benefit from this treatment, and how new drugs on the horizon may increase the ability to treat PPD in a variety of patient populations.

Indexed as

beta-CyclodextrinsDepression, PostpartumDrug ApprovalDrug CombinationsFemaleHumansPregnanoloneUnited StatesUnited States Food and Drug Administrationbeta-CyclodextrinsbrexanoloneDrug CombinationsPregnanoloneAntidepressantsBrexanoloneGABA(A) receptor modulatorsNeurosteroidsPostpartum depressionZulresso

Identifiers

PMID31584571
PMCPMC8033597
OpenAlexW2979086486

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.