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Novel pill shows promise in treating postpartum depression
One in eight women experience perinatal or postpartum depression, research suggests
A novel investigational postpartum depression pill has shown significant improvement in depressive symptoms in Phase 3 clinical trial.
The Feinstein Institutes for Medical Research at Northwell Health have announced the results from the SKYLARK Study, a phase 3 placebo-controlled clinical trial of an investigational oral, neuroactive steroid zuranolone pill in the treatment of postpartum depression, demonstrating the drug showed rapid, clinically meaningful improvements in depressive symptoms at measured time points.
This would support the potential for the US Food and Drug Administration (FDA) approval of the first oral, at-home, neuroactive steroid therapy to treat PPD.
Approximately one in eight women experience perinatal or postpartum depression (PPD) and current treatment options such as therapy can take months for new mothers to find symptom relief.
The trial, led by Dr Kristina M. Deligiannidis – professor at the Institute of Behavioral Science at the Feinstein Institutes – and published in The American Journal of Psychiatry, has shown a 14-day treatment with zuranolone versus placebo resulted in “significant” improvement in depressive symptoms.
At day 15, the study’s primary outcome measure, with statistically significant improvement in depressive symptoms, reported as early as day three and with improvements sustained at all measured time points through day 45.
Results showed that 57 per cent of the women taking zuranolone versus 38 per cent of women taking placebo experienced a 50 per cent or more improvement in their depressive symptoms at day 15.
At day 45, 61 per cent of the trial participants who received zuranolone compared to 54 per cent of women receiving placebo, experienced a 50 per cent or more improvement in their depressive symptoms.
“Postpartum depression is underrecognised, undertreated and disruptive for those who live with the condition, said” Dr. Deligiannidis, the trial’s principal investigator and lead author of the paper.
“We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support.
“We have been working on neuroactive steroid research in PPD for nearly 15 years. The SKYLARK study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression.”
Among the 200 enrolled patients and randomised diverse patients screened across international clinical sites, 196 female patients between ages 18 to 45 with postpartum major depressive episodes received the blinded study drug.
Zuranolone (50mg) or placebo was given once daily for 14 days and the patient’s depressive symptoms were evaluated at several defined points in the study for 45 days.
In 2021, Dr Deligiannidis reported the publication of the phase 3 results of the ROBIN Study, which was published in the Journal of the American Medical Association (JAMA) Psychiatry.
The trial demonstrated the improvement in depressive symptoms with zuranolone at 30mg versus placebo in patients with PPD and that zuranolone was generally well tolerated.
Evidence suggests that PPD is partly due to a disruption in the normal interaction between the nervous system’s stress response, ɣ-aminobutyric acid (GABA) signalling, and neuroactive steroids (NAS).
The SKYLARK and ROBIN clinical trials, researchers say, could provide some of the most substantial results for improving depressive symptoms in women with PPD.
Dr Kevin Tracey, president and CEO of the Feinstein Institutes, said: “Dr Deligiannidis is a leader in postpartum depression medical research.
“These clinical trial results are evidence that years of perseverance and dedication lead to significant advances in medicine.”
Apple announced menopause and perimenopause tracking for its Health app at WWDC 2026, with symptom logging and cycle alerts for some users.
The update expands the app’s cycle tracking beyond fertility and menstrual periods.
If logged cycle patterns suggest a user may be experiencing perimenopause, the app will send a notification prompting a conversation with a doctor.
However, this perimenopause-specific cycle deviation notification is only for users aged 40 and over and is not intended to replace a doctor’s diagnosis or treatment.
Stacey Ford, Apple’s vice-president of OS management, said users will also be able to log menopause and perimenopause symptoms in the Health app.
Educational content will also be available to help users learn more about these life stages and understand changes in their bodies.
Every year, about 2 million women enter perimenopause, the stage before menopause when levels of the hormone oestrogen decline.
According to a February 2025 survey involving 4,432 participants aged over 30, more than half of women aged 30 to 35 experienced moderate or severe perimenopause symptoms.
The findings suggest perimenopause does not affect only older adults.
About 6,000 women in the US enter menopause every day, according to the Society for Women’s Health Research.
Given the number of women affected by perimenopause and menopause, the update broadens the Health app’s scope.
The app launched in 2019, meaning it has gone seven years without these women’s health tracking features, which could help users better understand their bodies and prepare for informed conversations with doctors.
A £50m maternity consortium will bring together UK clinicians, researchers and communities to tackle the most critical gaps in maternal care.
Funding from the National Institute for Health and Care Research has established the NIHR Inequalities Challenge: Maternity Disparities Consortium under the leadership of the University of Birmingham and Newcastle University.
Higher education bodies, NHS organisations, community groups and voluntary organisations from across the UK will work together through the programme.
The NIHR has committed £50m over five years to support research led by clinicians, researchers and communities across the consortium.
Professor Joht Singh Chandan, consortium co-lead for research at the University of Birmingham, said: “National attention on maternity safety and equity has never been greater, but ambition must now be matched by evidence and implementation.
“Through this consortium, we will work across the UK to understand what works, for whom and in what contexts, and to ensure that research leads to practical changes in care for the women, babies and families who need them most.”
The launch comes at a pivotal moment for UK maternity care, with growing national attention on improving safety, equity and women’s experiences of care.
The government’s renewed Women’s Health Strategy highlights the need to improve care before and between pregnancies for underserved communities.
Against that backdrop, the consortium will generate the evidence, interventions and research capacity needed to help turn national ambition into practical improvements for women, babies and families.
University of Birmingham is leading work to improve maternity care pathways across the antenatal, intrapartum and postnatal periods.
Antenatal care covers pregnancy before labour, while intrapartum care refers to care during labour and birth.
The consortium will examine how women and families can be better supported before pregnancy and between pregnancies.
This includes improving access to advice and care that can help people prepare for pregnancy, manage existing health conditions and reduce risks before they build up.
Other research will focus on improving care during pregnancy, birth and the early weeks after birth.
This will include work on major causes of poor maternal health, such as high blood pressure, diabetes in pregnancy, obesity, perinatal mental health and complications during recovery after birth.
Professor Judith Rankin OBE, consortium co-lead for research and capacity development at Newcastle University, said: “This funding represents a critical opportunity to make the step change we need to improve outcomes for women and their babies.
“Alongside the research, the Consortium will be investing in tomorrow’s research leaders today to ensure we have the capacity to deliver on improving pregnancy outcomes, access to, and experience of, care.”
Peers have called for law reform after two House of Lords debates on fertility treatment, surrogacy, embryo research and declining birthrates.
The first debate was put forward by crossbench peer Baroness Ruth Deech, who previously chaired the UK’s fertility regulator, the Human Fertilisation and Embryology Authority.
She discussed proposals from the HFEA to reform the Human Fertilisation and Embryology Act, along with proposals from the Scottish Law Commission and the Law Commission of England and Wales to reform the Surrogacy Arrangements Act.
She called for parliamentary scrutiny of possible changes to regulatory powers, consent rules, donor information and future scientific developments.
Baroness Deech said: “Parliament should plan by setting up a Select Committee to examine the HFEA’s proposals to expand regulatory powers, simplify consent rules, modernise donor information provisions and create a flexible framework for future scientific developments.”
Former fertility professionals were among those contributing to the debate.
Professor Lord Robert Winston, a Labour peer who founded the IVF service at Hammersmith Hospital in London, said: “Infertility is not a disease; it is actually a symptom of something wrong.”
Professor Baroness Geeta Nargund, a Labour peer, current HFEA member and former medical director of CREATE Fertility, disagreed.
She said: “Infertility is a disease, as stated by the World Health Organisation.”
Liberal Democrat peer Baroness Caroline Pidgeon highlighted regional differences in access to NHS-funded fertility treatment.
She cited figures from the Progress Educational Trust’s NHS Fertility Funding Tracker showing that only two of England’s 42 integrated care boards comply with the recently updated fertility guideline published by the National Institute for Health and Care Excellence.
Integrated care boards are local NHS organisations responsible for planning and funding healthcare services in their areas.
Baroness Pidgeon said many boards were offering only a partial IVF cycle rather than a full cycle as defined by NICE.
A full IVF cycle generally includes ovarian stimulation, egg collection and the transfer of all suitable fresh and frozen embryos created during treatment.
Crossbench peer Professor Baroness Clare Gerada, a former president of the Royal College of General Practitioners, said: “The proportion of NHS-funded IVF cycles has fallen to just under 30 per cent, the lowest level since 2008.”
She added that, in relation to IVF, “the NHS system has collapsed”.
Liberal Democrat peer Lord Monroe Palmer said it was “very ironic that it is difficult for many patients to access publicly funded fertility treatment in the very country where IVF was originally pioneered”.
Conservative peer Edward Howard, Earl of Effingham, also raised concerns about the NICE fertility guideline.
He said: “Access remains highly variable across England, because ICBs are not required to implement that guidance.”
He described the situation as “a clear gap between guidance and enforceable entitlement”.
Baroness Deech called for “automatic record sharing between clinics and the NHS central records system”.
Baroness Nargund supported this and linked the ambition to the Single Patient Record in the government’s Ten-Year Health Plan for England and the Health Bill currently before Parliament.
Baroness Pidgeon said such ambitions were at odds with the exceptional degree of medical secrecy that currently applies to IVF.
She also pointed to “a clear desire for the HFEA to be able to permit patients to give generic consent for the use of their embryos in research”.
Patients cannot currently give broad consent for unspecified future research involving their embryos.
Responding for the government, Labour peer Baroness Judith Blake said “immediate legislative reform” was not possible because “the legislative programme for this Parliamentary session is very full”.
Baroness Deech replied: “It might well take some years, but the Government really needs to set up that Select Committee and do the legislative scrutiny right now.”
A second debate on related issues followed immediately afterwards.
Baroness Nargund asked the government “what assessment they have made of the UK’s declining birthrates in an ageing population”.
She also said: “We still have a postcode lottery for IVF provision, with nearly 70 per cent of ICBs funding only one cycle of treatment.”
Responding for the government, Labour peer Lord Philip Wilson said: “The Government are committed to improving fair and equitable access to fertility services, recognising the significant emotional and health impacts of infertility.”
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