Zuranolone Concentrations in the Breast Milk of Healthy, Lactating Individuals DOI Creative Commons
Kristina M. Deligiannidis, Amy Bullock,

Indrani Nandy

et al.

Journal of Clinical Psychopharmacology, Journal Year: 2024, Volume and Issue: unknown

Published: May 13, 2024

Abstract Purpose/Background Zuranolone is a positive allosteric modulator of both synaptic and extrasynaptic γ-aminobutyric acid type A receptors neuroactive steroid approved as an oral, once-daily, 14-day treatment course for adults with postpartum depression in the United States. This study assessed zuranolone transfer into breast milk. Methods/Procedures Healthy, nonpregnant, lactating adult female participants received once-daily 30 mg from day (D)1 through D5 this phase 1 open-label study. The relative infant dose (RID; weight-adjusted proportion maternal milk over 24 hours) was at D5. An RID 50 estimated using simulation approach across range ages weights. Findings/Results Of 15 enrolled (mean age, 30.1 years), 14 completed mean 0.357%; steady-state volume D3 to decreased baseline by 8.3%. Overall unbound plasma low (≤0.49%). Plasma concentrations peaked before decreasing biexponential manner. There strong concordance between temporal evolution based on intake 200 mL/kg per 0.984%. All treatment-emergent adverse events reported were mild, most common being dizziness (n = 3). Implications/Conclusions healthy, low; <1%, well below <10% threshold generally considered compatible breastfeeding.

Language: Английский

Pregnancy and Parenthood Among US Surgical Residents DOI
Ruojia Debbie Li, Lauren M. Janczewski, Joshua S. Eng

et al.

JAMA Surgery, Journal Year: 2024, Volume and Issue: 159(10), P. 1127 - 1127

Published: July 17, 2024

The ability to pursue family planning goals is integral gender equity in any field. Procedural specialties pose occupational risks pregnancy. As the largest procedural specialty, general surgery provides an opportunity understand planning, workplace support for parenthood, obstetric outcomes, and impact of these factors on workforce well-being, equity, attrition.

Language: Английский

Citations

9

Perceived Stress and Early Postpartum Depressive Symptoms in Women with Recent GDM: Implications for Postpartum Lifestyle Programs DOI
Jennifer Dias,

Estelle C Kelty,

Jacinda M. Nicklas

et al.

Maternal and Child Health Journal, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 7, 2025

Language: Английский

Citations

1

Validation of the Japanese Version of Obstetric Quality of Recovery-11 Questionnaire and Its Association with Postpartum Depression and Functional Outcomes: A Prospective Observational Study DOI Open Access

Ayu Ishida,

Mitsuru Ida, Yusuke Naito

et al.

Journal of Clinical Medicine, Journal Year: 2025, Volume and Issue: 14(4), P. 1390 - 1390

Published: Feb. 19, 2025

Background/Objectives: The aim was to develop a Japanese version of the Obstetric Quality Recovery-11 questionnaire (ObsQoR-11J), assess its feasibility, reliability, and validity, investigate association with postpartum depression functionality. need for this study is underscored by limited availability ObsQoR-11 in different languages lack documentation on associations early recovery mid-term patient-reported outcomes. Methods: After translating ObsQoR-11J into Japanese, 138 patients who underwent non-emergent cesarean delivery were enrolled study. scores evaluated at 24 h, 3 days, 5 days post-surgery. between functionality, which assessed using Edinburgh Postnatal Depression Scale (EPDS) 1 months 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0, respectively, three after delivery, evaluated. Results: completion rate h 97.1% (134/138), mean post-surgery 67.2, 89.0, 96.3, respectively. Cronbach's alpha 0.77, Spearman correlation coefficient global health visual analog scale 0.43 (p = 0.03) h. score any measurement point significantly associated EPDS WHODAS2.0 adjusting clinically relevant factors (all p < 0.05). Conclusions: valid assessment tool, are outcome measures.

Language: Английский

Citations

1

Society for Maternal-Fetal Medicine Consult Series #62: Best practices in equitable care delivery–Addressing systemic racism and other social determinants of health as causes of obstetrical disparities DOI Open Access
Mara Greenberg, Manisha Gandhi, Christina M. Davidson

et al.

American Journal of Obstetrics and Gynecology, Journal Year: 2022, Volume and Issue: 227(2), P. B44 - B59

Published: April 2, 2022

Language: Английский

Citations

30

Preclinical and clinical pharmacology of brexanolone (allopregnanolone) for postpartum depression: a landmark journey from concept to clinic in neurosteroid replacement therapy DOI Creative Commons
Doodipala Samba Reddy, Robert H. Mbilinyi,

Emily R. Estes

et al.

Psychopharmacology, Journal Year: 2023, Volume and Issue: 240(9), P. 1841 - 1863

Published: Aug. 11, 2023

Abstract This article describes the critical role of neurosteroids in postpartum depression (PPD) and outlines landmark pharmacological journey brexanolone as a first-in-class neurosteroid antidepressant with significant advantages over traditional antidepressants. PPD is neuroendocrine disorder that affects about 20% mothers after childbirth characterized by symptoms including persistent sadness, fatigue, dysphoria, well disturbances cognition, emotion, appetite, sleep. The main pathology behind reduction neurosteroids, referred to withdrawal, concept pioneered our preclinical studies. We developed replacement therapy (NRT) rational approach for treating other conditions related deficiency, unveiling power novel anxiolytic-antidepressants. neurosteroid, (BX), progesterone-derived allopregnanolone rapidly relieves anxiety mood deficits activating GABA-A receptors, making it transformational treatment PPD. In 2019, FDA approved BX, an intravenous formulation allopregnanolone, NRT treat clinical studies, BX significantly improved within hours administration, tolerable side effects headache, dizziness, somnolence. identified molecular mechanism neuronal PPD-like milieu. involves activation both synaptic extrasynaptic which promote tonic inhibition serve key target conditions. Neurosteroids offer several antidepressants, rapid onset, unique mechanism, lack tolerance upon repeated use. Some limitations include aqueous solubility, limited accessibility, hospitalization treatment, oral product, serious adverse events at high doses. However, unmet need synthetic address this condition supersedes these limitations. Recently, we hydrophilic superior profile drug delivery. Overall, approval major milestone field neurotherapeutics, paving way development depression, epilepsy, status epilepticus. Graphical abstract

Language: Английский

Citations

20

The magnitude and sustainability of treatment benefit of zuranolone on function and well-being as assessed by the SF-36 in adult patients with MDD and PPD: An integrated analysis of 4 randomized clinical trials DOI Creative Commons
Anita H. Clayton, Ellison Suthoff, Rakesh K. Jain

et al.

Journal of Affective Disorders, Journal Year: 2024, Volume and Issue: 351, P. 904 - 914

Published: Feb. 5, 2024

Major depressive disorder (MDD) and postpartum depression (PPD) are disabling conditions. This integrated analysis of MDD PPD clinical trials investigated the impact zuranolone—a positive allosteric modulator synaptic extrasynaptic GABAA receptors neuroactive steroid under investigation for adults with approved as an oral, once-daily, 14-day treatment course in US—on health-related quality life, including functioning well-being, assessed using 36-item Short Form Health Survey V2 (SF-36). Integrated data from 3 (201B, MOUNTAIN, WATERFALL) 1 trial (ROBIN) individual SF-36 domains were compared zuranolone (30- 50-mg) vs placebo at Day (D)15 D42. Comparisons between responders (≥50 % reduction baseline 17-item Hamilton Depression Rating Scale total score) nonresponders assessed. Overall, 1003 patients included (zuranolone, n = 504; placebo, 499). Significant differences change (CFB) to D15 groups observed 6/8 domains; changes sustained or improved D42, significant CFB all 8 domains. Zuranolone had significantly higher scores D42 (p < 0.001). Two doses across populations 2 disease states potential functioning, comorbidities, patient demographics. All p-values presented nominal. 4 showed improvements well-being Benefits persisted after completion

Language: Английский

Citations

6

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression DOI Open Access
Samantha Meltzer‐Brody, Margaret E. Gerbasi,

Catherine Mak

et al.

Journal of Medical Economics, Journal Year: 2024, Volume and Issue: 27(1), P. 582 - 595

Published: March 25, 2024

Aims: Estimate relative efficacy of zuranolone, a novel oral, Food and Drug Administration-approved treatment for postpartum depression (PPD) in adults vs. selective serotonin reuptake inhibitors (SSRIs) combination therapies used PPD the United States.

Language: Английский

Citations

6

Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders DOI Creative Commons
Autumn Walkerly, Lauren D. Leader, Emily Cooke

et al.

Drug Design Development and Therapy, Journal Year: 2021, Volume and Issue: Volume 15, P. 3017 - 3026

Published: July 1, 2021

Objective: This paper reviews the current literature available for efficacy and safety of allopregnanolone agonists discusses considerations their place in therapy. Literature Search: A search was conducted utilizing PubMed, clinicaltrials.gov, manufacturer's website. Data Synthesis: One phase II trial two III trials evaluating brexanolone were identified. Brexanolone demonstrated through significantly reduced Hamilton Depression Rating Scale (HAM-D) scores compared to placebo treatment postpartum depression (PPD). Noted adverse effects somnolence dizziness, excessive sedation, loss consciousness. published study interim results one on zuranolone included this review. Zuranolone, an oral agonist, is given as a single, 14-day course. significant reduction HAM-D patients with major depressive disorder (MDD) at 15 28 days placebo. Interim PPD bipolar (BPD) show promising reductions scores. Adverse headache. Place Therapy: Allopregnanolone seem have role when weighing quick onset action potential risks untreated PPD. The class medications limited by single course indication may fit bridge maintenance therapy selective serotonin reuptake inhibitors (SSRIs). Brexanolone, specifically, hindered long infusion time, hospitalization associated administration, risk evaluation mitigation strategy program. Zuranolone also MDD or BPD, but more data are needed. Conclusion: present novel mechanism disorders. Clinical support PPD, MDD, BPD. Keywords: postpartum, bipolar, brexanolone,

Language: Английский

Citations

41

Giving birth during the COVID‐19 pandemic, perspectives from a sample of the United States birthing persons during the first wave: March‐June 2020 DOI Open Access
Rachel Blankstein Breman, Carrie E. Neerland, Danielle Bradley

et al.

Birth, Journal Year: 2021, Volume and Issue: 48(4), P. 524 - 533

Published: June 11, 2021

Abstract Background The COVID‐19 pandemic forced hospitals in the United States to adjust policy and procedure order provide safe care prevent spread of disease. At beginning pandemic, media case reports described pressure for medical interventions, visitor restrictions, separation from newborns, an increase patient demand community birth (home center). purpose this study was describe experiences during centering birthing person's perspective. Methods A survey e‐mailed users Ovia Pregnancy app reaching a national convenience sample who gave between March 1, 2020, June 11, 2020. Survey topics included location, Mothers on Respect index, open‐ended questions capturing perspectives pandemic's effect their experiences. Differences were assessed based state‐level COVID rate by race. Content analysis performed analyze responses. Results Respondents highly impacted states more frequently changed or considered changing location. Racial differences also found with Black respondents reporting significantly preterm births lower respect scores when compared White respondents. Six themes emerged content analysis: Institutional Policies, Changes Care, Hospital Staff Interactions, Sub‐par Issues Support, Mental Health . Discussion health must continue adapt policies procedures best support patients pandemic. address reality that receive less respectful patients.

Language: Английский

Citations

40

Development of neuroactive steroids for the treatment of postpartum depression DOI
Handan Gunduz‐Bruce, Koji Takahashi, Ming‐Yi Huang

et al.

Journal of Neuroendocrinology, Journal Year: 2021, Volume and Issue: 34(2)

Published: July 27, 2021

Postpartum depression (PPD) is a common major depressive episode surrounding childbirth, with estimated rates ranging from 5.5% to 23.5% of all live births across Europe and the USA based on presence key symptoms. PPD has been associated significant impairments in both maternal functioning mother-infant attachment, these can have lasting effects emotional cognitive development children. Although precise pathophysiology unknown, preclinical findings suggest that large fluctuations neurosteroid hormone levels induce physiological plasticity expression functional GABAA receptors during pregnancy postpartum period, deficits this may underpin biological mechanism contributes manifestation Here, we review controlled clinical trials date assessed efficacy pharmacological treatments for PPD, including oestradiol, selective serotonin reuptake inhibitors, brexanolone (an iv formulation allopregnanolone) an investigational neuroactive steroid positive allosteric modulator, zuranolone. Coupled GABAergic implicated disorder, highlight not only potential role receptor but also novel therapeutic approach using modulators targeting transmission treat women affected by PPD.

Language: Английский

Citations

39