A single day of inhaled psychedelic treatment may relieve postpartum depression symptoms, with effects lasting for a week, early research suggests.

Postpartum depression is a severe mood disorder that affects women after giving birth. Symptoms can include extreme sadness, anxiety, changes in sleep and eating habits and difficulty bonding with a baby.

The condition affects up to one in five mothers globally. If untreated, it can have lasting effects on a mother’s psychological wellbeing and a child’s cognitive development.

Standard antidepressants, including selective serotonin reuptake inhibitors, a common type of antidepressant, often take four to six weeks to start working.

They can also cause side effects including weight gain, nausea and sexual dysfunction.

The only medication specifically approved by the US Food and Drug Administration for postpartum depression is zuranolone. It works faster than standard antidepressants but requires a 14-day daily course and carries warnings about drowsiness.

Researchers are exploring psychoactive compounds as possible alternatives for faster relief.

Mebufotenin, also known as 5-MeO-DMT, is a psychedelic compound that acts on serotonin receptors in the brain. Serotonin is a chemical messenger involved in functions including mood, sleep and digestion.

Previous early-stage trials found that an inhaled synthetic formulation called GH001 produced very rapid antidepressant effects in people with treatment-resistant depression.

Lead authors Martin Johnson of St Pancras Clinical Research and Kristina M. Deligiannidis of the Feinstein Institutes for Medical Research investigated whether the treatment could safely help women with severe postpartum depression.

The trial assessed its safety, side effects and impact on maternal functioning. It was funded by GH Research, the company developing the drug.

Researchers enrolled 10 women aged 18 to 45. All had major depressive disorder that began shortly before or after giving birth and were at least four weeks postpartum.

Participants also had to score at least 28 on a standard depression questionnaire, indicating moderate to severe depression.

Treatment was given on a single day using a specialised vaporisation system, with patients inhaling the medication from a collection balloon.

Doses were adjusted according to each woman’s response.

Participants first received 6mg. Those who tolerated the drug but did not experience a sufficiently intense psychoactive effect could receive 12mg one hour later, followed by 18mg after another hour if needed.

Researchers used a specialised scale to assess the intensity of the psychedelic experience, including feelings of losing control and how profound the experience felt.

Further doses were stopped once participants reached a predefined score.

Patients were monitored for changes in vital signs, psychiatric symptoms and overall comfort.

The psychedelic effects lasted for an average of around 20 to 25 minutes after each dose.

Participants also had to arrange for a trusted adult to care for their baby while they received treatment.

The main measure was the change in depression scores between the start of the study and day eight. Researchers also measured symptoms two hours after the final dose and on day two.

Four participants were lactating, allowing researchers to test their breast milk and assess how quickly the drug was eliminated from their bodies.

All 10 women experienced at least a 50 per cent reduction in depression symptoms two hours after their final dose.

By day eight, average depression scores had fallen by around 96 per cent and every participant met the study criteria for remission, meaning they no longer met the clinical threshold for depression.

Participants also reported improvements in maternal functioning.

Scores on a questionnaire assessing psychological wellbeing, self-care and mother-child interaction improved by around 56 per cent by day eight, with gains seen across almost all areas measured.

No serious adverse events were reported.

The most common side effect was mild to moderate headache, experienced by five of the 10 women.

The treatment did not cause lingering sedation and all participants were able to return home on the day they received it.

Among the four lactating women, levels of the drug and its byproducts in breast milk peaked around one hour after the final dose and fell below detectable levels after about 10 hours.

Researchers said this suggests mothers may only need to pause breastfeeding for a relatively short period on the day of treatment, although further research is needed before firm clinical recommendations can be made.

The trial was open-label, meaning both participants and researchers knew the active drug was being given.

There was no placebo comparison group, making it impossible to rule out the possibility that expectations about the treatment influenced the reported improvements.

The sample was also small and lacked demographic diversity, with nine of the 10 participants identified as white.

Almost none of the women were taking other psychiatric medications during the trial, meaning the findings may not reflect how a broader and more diverse group of mothers with postpartum depression would respond.

Researchers followed the women for only one week after treatment, leaving questions about how long the antidepressant effects may last.

Future studies will need to follow patients for several months to assess whether depression returns or additional doses are needed.

Larger trials will also need to randomly assign participants to receive either the active treatment or a placebo.

These studies will be needed to confirm the treatment’s safety and determine whether the drug itself is responsible for the rapid reduction in symptoms.

Weekly app monitoring can reduce fatigue and improve daily life for women with metastatic breast cancer, according to a study.

The approach involves regularly asking patients about their wellbeing through an app and responding quickly when problems are identified.

Germany’s Federal Joint Committee, known as the G-BA, has recommended that the treatment model be incorporated into standard care.

Professor Maria Karsten, senior attending physician at the Charité Breast Cancer Center and initiator of the PRO B project, said: “The new medications often no longer need to be administered at the hospital but can be taken at home.

“As a result, we see patients less frequently at the hospital, and our medical oversight has become somewhat incomplete.

“In order to close this gap and provide patients with close support in spite of the distance, we have developed the PRO B digital treatment concept.”

Around 68,000 women in Germany are living with metastatic breast cancer, meaning the disease has spread to other organs.

At this stage, the cancer is generally considered incurable. Modern treatments can, however, temporarily control the disease and extend life expectancy by several years, with some women able to continue working.

At the centre of PRO B is an app that asks women up to 52 structured questions once a week about their symptoms, daily life and emotional wellbeing.

Questions include whether they have experienced pain, felt too tired to carry out their usual activities or experienced shortness of breath.

An algorithm analyses the answers and immediately alerts the treatment team when relevant changes are detected.

The team then contacts the patient within 48 hours to decide whether any action is needed.

Karsten said: “During these phone calls, for example, we discuss whether the dosage of anti-nausea medication should be adjusted or offer practical tips for managing the various symptoms.

“But we also detect serious side effects more quickly – such as those indicated by a seemingly harmless symptom like fatigue – and can immediately schedule the patient for an appointment at the hospital.”

The study involved 909 women with metastatic breast cancer aged 19 to 81 across 52 breast cancer centres in Germany and followed them for one year.

Around half received PRO B care alongside drug-based cancer treatment.

The other half answered questions about their wellbeing once every three months and were not contacted by their treatment teams in response.

Women receiving PRO B care reported significantly less fatigue, which refers to physical, emotional or mental exhaustion that can severely restrict daily life.

They also rated their physical functioning more positively and required fewer hospital admissions.

Karsten said: “These are effects that have a noticeable impact on the patients’ daily lives; the women are more capable and better able to manage their lives.

“We even have evidence that the PRO B approach extends the remaining lifespan for some patients. We are achieving all of this not through a new medication, but simply by regularly and systematically assessing the women’s well-being and responding accordingly.”

More than 90 per cent of women in the PRO B group said after the study that they wanted the approach to become part of routine care.

Stephanie Neumann-Johnston, 51, who took part in the study, said: “I feel like the app has saved my life several times.

“There are so many situations and incidents that you can’t make sense of – you have so many questions.

“With the app, I can look up common problems and find medically reviewed information, for example, about fatigue. That way, I can help myself, also on the weekends.

“And the personal contact provides me with emotional and medical support.

“For example, I can find out whether I’m allowed to take certain medication for a fever, or get an assessment of my situation: Should I go to the emergency department with these symptoms or not? The app takes a huge weight off your shoulders.”

Based on the medical findings and a health economic analysis, the G-BA recommended in June that PRO B should be incorporated into standard care.

This would allow patients with statutory health insurance to access the model in future when they receive the relevant diagnosis.

PD Dr Christoph Kowalski, department director at the German Cancer Society and a co-author, said: “This recommendation must now be implemented as quickly as possible.

“If a new care concept offers medical and economic benefits, we should not withhold it from the most seriously ill women.”

The health insurance companies involved in the project are also planning further developments so affected women can receive routine PRO B care before its wider introduction into standard care, with access expected to begin this autumn.

The care model will continue under the name “ida”, led by Karsten and her team.

The PRO B project ran from 2020 to 2024 and received around €4.8m from the Innovation Committee of the Federal Joint Committee.

The project was led by Karsten, with consortium partners BARMER, mkk – meine krankenkasse, DAK-Gesundheit, the German Cancer Society and OnkoZert GmbH.

Breast cancer is the most common cancer among women in Germany, with around one in eight expected to develop the disease during their lifetime.

Worldwide, breast cancer is the leading cause of cancer-related deaths.

Despite advances in treatment, 30 per cent of women with early-stage breast cancer and up to 70 per cent of those with lymph node involvement in later stages develop distant metastases, which typically make the disease incurable.

For patients with metastatic breast cancer, treatment aims to prolong life while maintaining the best possible quality of life.

Since 2016, the G-BA has been responsible for supporting new forms of care that go beyond existing standards, as well as health services research aimed at improving healthcare quality in Germany.

Its Innovation Fund is financed through contributions from statutory health insurance plans and the Health Fund.

Higher cumulative doses of common fertility drug clomiphene citrate may increase pregnancy loss risks, according to new research.

Around one in six people experience infertility, with irregular or absent ovulation among the most common causes.

Clomiphene citrate has long been a mainstay of fertility treatment, but Adelaide University research has raised concerns about higher cumulative doses.

The new study found that high doses of clomiphene citrate accumulated over multiple fertility treatment cycles could increase the risk of pregnancy loss.

Lead author associate professor Sheree Boulet said the findings showed a clear dose-response relationship, meaning the risks increased as cumulative exposure rose.

She said: “Women who received higher cumulative doses of clomiphene citrate experienced progressively greater risks of adverse pregnancy outcomes.

“We examined more than 21,000 embryo transfer cycles across four cumulative dose categories and found that increasing the dose did not significantly improve the chance of a live birth.

“Our findings suggest there may be a point where increasing the dose offers little additional benefit while exposing women to greater risk, highlighting the importance of carefully balancing effectiveness with safety when making treatment decisions.”

Supported by the NHMRC and conducted in partnership with Boston University and the Centers for Disease Control and Prevention, researchers analysed 21,004 IVF embryo transfer cycles in the US.

Women receiving cumulative doses of 500mg to 749mg of clomiphene citrate had a 12 per cent higher risk of miscarriage, while those receiving 750mg to 999mg had a 38 per cent higher risk.

Women receiving cumulative doses of 750mg or more were also more than twice as likely to have twins or other multiple births.

Rates of spontaneous abortion, another term for miscarriage, increased as the dose rose.

Researchers also recorded more than a threefold increase in stillbirth at the highest dose, although the finding was not statistically significant because that dose was rare. Larger studies are needed to confirm the association.

The finding is consistent with an earlier Adelaide University study that showed a doubling of neonatal death in pregnancies involving clomiphene citrate. Neonatal death means the death of a baby shortly after birth.

Higher cumulative doses did not improve the chance of a live birth, but did increase twinning, which raises the risk of adverse outcomes for both mother and child.

Clomiphene citrate is one of the world’s most widely prescribed fertility drugs. It has been prescribed to millions of women worldwide since 1967 and remains a recommended first-line treatment for ovulation induction.

The drug is recognised as an essential medicine by the World Health Organization. It works by stimulating the ovaries to release eggs, increasing the chance of pregnancy.

Women who do not respond to lower doses, or who require multiple treatment cycles, may receive progressively higher cumulative doses over time.

The findings build on a series of studies from Adelaide University’s Robinson Research Institute linking clomiphene citrate with increased risks of pregnancy loss, stillbirth, perinatal death and some birth defects.

Experimental studies in mice supported these findings, showing that higher doses reduced successful pregnancies and were associated with pregnancy loss, impaired fetal growth and developmental abnormalities.

Professor Michael Davies, senior researcher and co-author of all the studies, said the latest work builds on more than two decades of Adelaide-led research into the safety of fertility treatments.

He said: “Clomiphene citrate has been used by many women since 1967, but it has never been comprehensively evaluated in large prospective clinical trials.

“Our studies indicate that women respond differently to clomiphene citrate and that increasing cumulative doses may increase the risk of adverse pregnancy outcomes without improving the likelihood of a live birth.

“The findings confirm and extend our previous studies in both human and mouse models which highlight the need to better understand the dose-response relationship and whether more personalised dosing strategies could improve safety.

“Until we can better understand these differences, it remains important that clinicians rigorously follow manufacturer’s safety recommendations and avoid unnecessarily increasing cumulative doses.

“The same questions are now being asked of newer ovulation-inducing medications, so any move away from clomiphene citrate should also be guided by robust evidence rather than assumptions about safety.”