Clinical Utility of Zuranolone for Postpartum Depression: A Narrative Review

Neuropsychiatric Disease and Treatment, Год журнала: 2025, Номер Volume 21, С. 93 - 105

Опубликована: Янв. 1, 2025

Peripartum depression (PPD) affects approximately one in every eight birthing individuals. Despite a high prevalence, PPD is underdiagnosed and undertreated. Several treatment options exist including psychotherapies, conventional serotonergic-based antidepressants alternative integrative medicine approaches. Rapid-acting neuroactive steroid-based have been studied approved the United States (US) for of adult females with PPD. Zuranolone first US Food Drug Administration oral antidepressant This narrative review reports on evidence clinical utility zuranolone treatment. In double-blind, randomized, placebo-controlled, trials, demonstrated rapid, statistically significant clinically meaningful improvements depressive symptoms. Most common adverse events reported use were somnolence, dizziness, sedation, headache. No changes vital signs, electrocardiogram or lab parameters observed. loss consciousness no increase suicidal ideation from baseline deaths seen studies. Secondary analyses that improves comorbid symptoms anxiety insomnia some measures health-related quality life. relevant infant dose lactation data suggest its compatible breastfeeding, though future research needed to measure potential effects breastfed infant. Key aspects decision-making patients are discussed.

Язык: Английский

---

Development of neuroactive steroids for the treatment of postpartum depression

Journal of Neuroendocrinology, Год журнала: 2021, Номер 34(2)

Опубликована: Июль 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.

Язык: Английский

---

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

American Journal of Obstetrics and Gynecology, Год журнала: 2022, Номер 227(2), С. B44 - B59

Опубликована: Апрель 2, 2022

Язык: Английский

---

Association between urban green space and postpartum depression, and the role of physical activity: a retrospective cohort study in Southern California

The Lancet Regional Health - Americas, Год журнала: 2023, Номер 21, С. 100462 - 100462

Опубликована: Март 6, 2023

Little research exists regarding the relationships between green space and postpartum depression (PPD). We aimed to investigate PPD exposure, mediating role of physical activity (PA). Clinical data were obtained from Kaiser Permanente Southern California electronic health records in 2008–2018. ascertainment was based on both diagnostic codes prescription medications. Maternal residential exposures assessed using street view-based measures vegetation types (i.e., tree, low-lying vegetation, grass), satellite-based [i.e., Normalized Difference Vegetation Index (NDVI), land-cover space, tree canopy cover], proximity nearest park. Multilevel logistic regression applied estimate association PPD. A causal mediation analysis performed proportion mediated by PA during pregnancy total effects In total, we included 415,020 participants (30.2 ± 5.8 years) with 43,399 (10.5%) cases. Hispanic mothers accounted for about half population. reduced risk associated exposure street-view measure [500 m buffer, adjusted odds ratio (OR) per interquartile range: 0.98, 95% CI: 0.97–0.99], but not NDVI, greenness, or a Compared other coverage showed stronger protective (500 OR = 0.97–0.99). The proportions attributable ranged 2.7% 7.2% across indicators. Street decreased observed primarily due increased coverage, rather than grass. Increased plausible pathway linking lower National Institute Environmental Health Sciences (NIEHS; R01ES030353).

Язык: Английский

---

Preclinical and clinical pharmacology of brexanolone (allopregnanolone) for postpartum depression: a landmark journey from concept to clinic in neurosteroid replacement therapy

Psychopharmacology, Год журнала: 2023, Номер 240(9), С. 1841 - 1863

Опубликована: Авг. 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

Язык: Английский

---

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

Journal of Affective Disorders, Год журнала: 2024, Номер 351, С. 904 - 914

Опубликована: Фев. 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

Язык: Английский

---

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression

Journal of Medical Economics, Год журнала: 2024, Номер 27(1), С. 582 - 595

Опубликована: Март 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.

Язык: Английский

---

Addressing Perinatal Mood and Anxiety disorders in Obstetric Settings: Results of a Cluster Randomized Controlled Trial of Two Approaches

American Journal of Obstetrics & Gynecology MFM, Год журнала: 2025, Номер unknown, С. 101599 - 101599

Опубликована: Янв. 1, 2025

Язык: Английский

---

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

Maternal and Child Health Journal, Год журнала: 2025, Номер unknown

Опубликована: Фев. 7, 2025

Язык: Английский

---

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

Journal of Clinical Medicine, Год журнала: 2025, Номер 14(4), С. 1390 - 1390

Опубликована: Фев. 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.

Язык: Английский

---