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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.”
Osteoporosis may raise the risk of death in postmenopausal women by up to 47 per cent, a new study suggests.
The findings point to an inverse relationship between femoral bone mineral density and mortality risk, especially within certain ranges.
Femoral bone mineral density is the amount of mineral in the thigh bone, which is often measured to assess bone strength and osteoporosis risk.
Dr Monica Christmas is associate medical director for The Menopause Society.
She said: “Osteoporosis often remains a silent threat after menopause, despite its profound effect on women’s lives—from loss of height, poor balance, and reduced mobility to disfigurement, pain, and even premature death.
“Early screening and preventive measures, including a calcium-rich diet (preferably from food sources), regular weight-bearing exercise, and hormone therapy when appropriate, can significantly improve bone health and reduce risks not only of fractures but also cardiovascular disease, certain cancers, and dementia.
“It’s time we bring this conversation to the forefront.”
In the study involving nearly 3,000 postmenopausal women, bone mineral density at four femoral sites was assessed using dual-energy x-ray absorptiometry, a scan commonly used to measure bone strength and fracture risk.
The analysis found that mortality risk was significantly higher when femoral bone mineral density reached the osteoporotic threshold or when osteoporotic fractures were present.
After full adjustment, osteoporosis was associated with a 47 per cent increased risk of mortality.
A stronger inverse association between increased bone mineral density and mortality risk was seen within specific ranges, suggesting bone mineral density could serve as a prognostic marker of wider health.
The relationship appeared especially notable within the range of 0.46 to 0.71 g/cm² for total femur bone mineral density.
Previous research has shown that postmenopausal women face a significantly higher risk of death within one year of hip or vertebral fractures.
After more than a decade of campaigning, doctors around the world have agreed to rename polycystic ovary syndrome (PCOS).
It is hoped the new name, polyendocrine metabolic ovarian syndrome, or PMOS, will help end the misconception that the condition is all about cysts, which campaigners say has contributed to missed diagnoses and inadequate treatment.
The condition affects one in eight women, or 3.1m women and girls in the UK, and is linked to hormone fluctuations that can affect weight, mental health, skin and the reproductive system.
The renaming was spearheaded by UK patient charity Verity alongside Professor Helena Teede, director of Melbourne’s Monash Centre for Health Research and Implementation.
It followed 14 years of consultation with clinicians and patients around the world.
The new name was published in a consensus statement on May 12 and announced at the European Congress of Endocrinology in Prague.
The paper states that PCOS should now be referred to as PMOS.
“This is a landmark moment that will lead to desperately-needed worldwide advancements in clinical practice and research,” said Professor Teede.
“It was heart-breaking to see the delayed diagnosis, limited awareness and inadequate care afforded those affected by this neglected condition.”
When doctors first named PCOS in 1935, they thought it was mainly caused by physical changes to the ovaries.
Decades of research have since changed that understanding, with clinicians now agreeing the condition is far more complex.
“What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” Professor Teede added.
“A name change was the next critical step towards recognition and improvement in the long term impacts of this condition.”
The exact cause of the condition is still unknown, though it is thought to be linked to abnormal hormone levels and is associated with insulin resistance and raised levels of testosterone and luteinising hormone.
Insulin resistance means the body does not respond properly to insulin, the hormone that helps control blood sugar. Luteinising hormone helps regulate ovulation.
Common symptoms listed by the NHS include irregular periods or no periods at all, difficulty getting pregnant, excessive hair growth, weight gain, thinning hair, oily skin and acne.
Campaigners have acknowledged that the name change could cause temporary confusion.
“Despite decades of tireless advocacy to improve awareness, we recognised that the risk of change would be worth the reward,” said Rachel Morman, chairwoman of Verity.
“This shift will reframe the conversation and demand that it is taken as seriously as the long-term, complex health condition it is.”
It is also unclear if, or when, the NHS will change the language it uses.
An NHS England spokesperson said: “We routinely review and update content on the NHS website to ensure it reflects the latest clinical advice and will carefully consider these recommendations.
“The NHS will also continue our work to improve women’s healthcare, including for this important group, which involves giving women more choice over their care, bringing down waiting times, and delivering more care in communities.”
Housing, work and fertility pressures are stopping many Britons growing the families they want, new research suggests.
A UK fertility report found that 79 per cent of people surveyed who had tried to conceive in the past five years would like more children than they currently have.
Among parents with one child, that figure rises to 88 per cent.
The report surveyed more than 1,000 people across the UK who had tried for a baby in the past five years.
While birth rates continue to fall, the findings suggest it is not because people no longer want children. Instead, many respondents said external pressures are making it harder to grow their families.
The findings, from wellness brand Wild Nutrition’s Fertility Disconnect report, highlight how financial pressures, fertility struggles and gaps in reproductive health knowledge are shaping modern family life in the UK.
Gail Madalena, fertility nutritional therapist at Wild Nutrition, said: “People often assume fertility begins the moment they decide to try [for a baby].
“In reality, egg and sperm health are shaped months and years earlier.
“By the time someone starts thinking about fertility, their body has already been responding to its environment for a long time.”
Among the biggest barriers, 26 per cent said career progression affected their family plans, 25 per cent cited housing affordability and lack of space, and 52 per cent said they required medical intervention during their fertility journey.
The report also found that almost a quarter of respondents had spent more than two years trying to conceive.
Trying for a baby can take a significant toll on mental health and relationships, especially for those navigating fertility treatment.
According to the research, 38 per cent of respondents said trying to conceive had negatively affected their mental health. That figure rose to 99 per cent among people undergoing fertility treatment.
Julianne Boutaleb is a perinatal psychologist.
She said: “Navigating a fertility journey is about so much more than medical appointments and procedures.
“It’s an emotional marathon that can take a huge toll on your mental wellbeing.
“Sadly, the stats show that 15 per cent of couples going through fertility treatment say their relationship has been irrevocably impaired.”
The report also highlighted the realities of secondary infertility, which affects around one in 20 people, challenging the assumption that having one child means conceiving again will be straightforward.
Researchers found many people felt under-informed about fertility, particularly younger adults.
Ten per cent of Gen Z respondents said they “know nothing” about fertility, while only one in five respondents said they know “a lot” about egg health.
The report also found that 60 per cent of women were unaware of fertility testing options, and one in five Gen Z respondents said they felt uncomfortable discussing fertility, even with their partner.
Around 40 per cent of those surveyed supported fertility education being included in schools, covering topics such as egg health, sperm health and hormonal health.
The report also explored how lifestyle and long-term health may influence fertility outcomes.
Many respondents said they only made changes once they started trying to conceive.
Some 44 per cent improved their diet when trying for a baby, while 32 per cent reduced alcohol intake at that stage.
The report also referenced emerging research that suggests ultra-processed foods and microplastics could have an impact on reproductive health.
While fertility conversations often focus on women, the findings showed male fertility issues are also affecting many families.
Seventeen per cent of respondents cited sperm health issues as a barrier to conception, while male factors contribute to around half of all fertility challenges.
Only one in four men said they would share fertility struggles with friends.
“Many causes of male infertility are entirely treatable yet so often the last resort is the first response,” said Ian Stones, co-founder at Test Him Ltd.
The findings come as UK birth rates remain below replacement level.
The report noted that the UK fertility rate is now 1.41, meaning that on average women give birth to 1.41 children over their lifetimes. The replacement rate, or rate that maintains population numbers, is 2.1.
It also said the average age of mothers has risen to 31, while birth rates are falling across most age groups except among over-40s.
“There is no single fertility story, and it is rarely a simple, linear narrative,” said Dr Zeynep Gurtin, lecturer in women’s health at UCL.
Dr Gurtin added that better fertility education, fairer access to treatment and more open conversations around infertility and pregnancy loss are needed.
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