Psych News - Early August 2025

This week’s psych news sees major developments across the board, from landmark clinical trials in Europe to bold policy recommendations in Australia and the US. New findings from around the world continue to reveal the wide-ranging benefits of psychedelics, including anxiety treatment, addiction therapy, and spiritual wellbeing, and even acceptance of gender identity. The psychedelic renaissance continues apace.

CYB003 Receives Regulatory Approval for MDD

On August 7th, Cybin, a leader in developing differentiated, next-generation therapeutics, received European regulatory approval to begin its Phase 3 EMBRACE study in Ireland, Greece, and Poland. The study has already been approved by the Healthcare Products Regulatory Agency (MHRA) in the UK. EMBRACE is the second study in Cybin’s PARADIGM program to assess the effectiveness of CYB003 as an adjunctive treatment for Major Depressive Disorder (MDD). CYB003 is a proprietary analogue of psilocin, the active ingredient in “magic mushrooms”.

EMBRACE will enrol 330 participants who live with moderate to severe MDD, whose symptoms are not adequately managed by traditional antidepressant treatments. This move ahead is supported by the promising Phase 2 data, which showed that 71% of participants treated with CYB003 were in full remission from their symptoms. 100% of participants responded to treatment at 12 months, after only two 16mg doses of CYB003. The primary goal of Phase 3 is to measure CYB003 against a placebo against the change in depressive symptoms six weeks following the initial dose.

The complete PARADIGM program will consist of 550 participants worldwide, with roughly 105 clinical sites in the US, Europe, the UK, and Australia. Thus far, conclusions are very positive, but Cybin does urge some caution, describing their conclusions so far, and future plans, as “forward-looking statements”, also stating that:

The efficacy of [psychedelics] has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition.

The Minnesota Psychedelic Medicine Task Force

Minnesota’s Psychedelic Medicine Task Force (PMTF) has recommended a comprehensive framework for legal, regulated access to psychedelic substances. It was established in 2023 to advise the Minnesota legislature of the legal, medical, and policy issues associated with the potential legalisation of psychedelic medicine.

The task force proposed a multi-faceted approach:

1. Decriminalisation of psychedelics (this only refers to psilocybin, LSD, and MDMA).
2. Establishment of a state-regulated clinical program.
3. Increased funding for psychedelic research.
4. Creating a state-regulated market for adult use of psilocybin mushrooms.

These recommendations aim to more accurately align health and safety, individual freedom, and wider access to potentially beneficial treatments. The medicinal element of the proposed changes would allow for the therapeutic use of psychedelics under qualified medical supervision. The decriminalisation aspect of the recommendations would remove criminal penalties solely for possession and personal use.By advocating for a regulated market for adult use of these substances, the task force is reflecting a growing national (and broadly international) trend towards reviewing and altering the legal status and potential medicinal applications of psychedelics. This underscores the need for increased research into, and better understanding of, the effects of these substances to further guide policy in the future.

Psychedelics Beneficial for the Clergy?

A recent study published in Psychedelic Medicine has revealed that psychedelic-naive religious leaders who participated in just two guided psilocybin sessions reported many positive changes. The study was carried out by Roland R. Griffiths and colleagues at Johns Hopkins University and involved 33 individuals holding well-known leadership positions within a variety of established religious bodies. Participants reported a perceived increase in their effectiveness in their religious roles, as well as improvements in their general well-being. When reviewed after six months following the second psilocybin session, participants confirmed the changes were still present. They reported more positive attitudes towards their faith itself, and further enhancements to their leadership abilities and religious practices.

All of these changes were largely sustained on a second 16-month follow-up. 96% of participants rated at least one of their psilocybin experiences as one of the top five most spiritually significant experiences of their lives. 92% described experiences as profoundly sacred, 83% psychologically insightful, and 79% psychologically meaningful.

The study authors concluded that:

In this population of clergy, psilocybin administration was safe and increased multiple domains of overall psychological well-being including positive changes in religious attitudes and behavior as well as their vocation as a religious leader. The study was limited by a waitlist control design, homogenous sample, and the use of some unvalidated outcome measures. Further research with more rigorous control conditions and diverse samples is needed.

So, while the results initially appear exceedingly positive, as ever with our early forays into the study of psychedelics, we must proceed with caution.

Experimental Psychedelics for Life-Threatening Diagnoses

Researchers at the University of New Mexico (UNM) are joining a multi-site clinical trial of an experimental drug, RE104, which is designed to assist patients with the trauma of receiving a life-threatening diagnosis. The REKINDLE trial will test the drug’s efficacy for patients diagnosed with conditions like cancer, ALS, multiple sclerosis, and Parkinson’s disease.

RE104 is a synthetic drug which is chemically similar to psilocybin. The psychedelic effects of the substance are designed to have a shorter duration – about three hours, as opposed to the 6-7 hours usually associated with psilocybin. The theory is that this could maintain the potential therapeutic benefits of psilocybin, but make the experience much more manageable.

The study aims to build upon existing research showing the benefits of psychedelic substances to tackle the symptoms of depression and anxiety. If successful, this could offer a new approach to palliative care. Lawrence Leeman of UNM explains:

This has the potential to alter the process of death and dying for a lot of people. A lot of us would probably agree that the fear of death in our society is very strong and often the way of dying is often very hard. If this is successful, it offers all sorts of different possibilities.

Psychedelics Help LGBTQ+ Identity and Wellbeing

A study of LGBTQ+ individuals who have used psychedelics has concluded that their experiences can significantly improve their mental health. The study, published in the Journal of Psychoactive Drugs, found that these effects helped to foster greater self-acceptance of their gender and sexual identities.

The study surveyed 346 people who identified across a diverse gender spectrum. A significant majority, 77.2%, believed in the potential of psychedelics to alleviate gender dysphoria. 65.3% reported that their experiences actively influenced their attitudes towards their gender identity. The research documented large reductions in symptoms of traumatic stress, anxiety, and depression, and a major increase in psychological flexibility.

Perhaps the most significant finding was the strong correlation between the reported intensity of the psychedelic experience and the perceived positive outcomes in self-acceptance and free exploration of identity. This suggests, perhaps, that the experience of ego-death or dissolution associated with high-dose psychedelics may be the reason for these lasting psychological changes following the experience. If this is the case, and higher doses do equal more pronounced benefits, it highlights the continuing importance of set and setting in future clinical sessions. Higher doses and the resulting ego-shattering experiences can be extremely challenging, so our therapeutic environments must have adequate controls in place to manage these challenges.

Australia’s Clinical Practice Guideline for MDMA

In 2023, Australia became the first country to reschedule MDMA from a prohibited to a controlled substance. Australia’s first clinical practice guideline for psychedelic-assisted therapy has been released for public review. Developed by Monash University, Melbourne, the guideline explains the appropriate clinical use of MDMA as an adjunct to the treatment of persistent PTSD.

The Guideline Development Group, which consisted of a diverse group of experts in fields such as neuroscience and psychiatry, as well as representatives from government agencies, non-profit, and consumer organisations, conditionally recommended against the routine use of MDMA for PTSD. However, the guideline does outline specific, controlled situations in which the substance could be administered. The document provides recommendations for both current clinical practice and future areas of possible research. The draft is open for comment from the public until 05/09/2025.

Rising Ketamine Addiction in the UK

A leading UK drugs expert has highlighted the growing issue of ketamine addiction, highlighting a major dilemma as researchers launch a new trial to test the drug’s effectiveness in treating chronic alcoholism. Professor Celia Morgan, of the University of Exeter’s Psychedelic Studies Transdisciplinary Research Group, is leading a Phase 3 clinical trial for ketamine-assisted therapy. The combination appears to hold significant promise for individuals with treatment-resistant addiction. However, Morgan highlights the risk of the surge of recreational misuse of ketamine, which can lead to serious health issues. Increasing calls for stricter regulation of the substance could significantly impact research efforts.

The rise in recreational use has prompted a political push for ketamine’s reclassification to a Class A substance, which would place it alongside psilocybin and MDMA. As we know, the legal barriers to research have hamstrung our efforts to understand the potential benefits of every psychedelic. Professor Morgan warns that while stricter regulation may be intended to protect the public, it may well have the opposite effect. If promising therapies such as ketamine for alcoholism are halted as a result, then in the long run, we may miss out on potentially breakthrough treatments and actively harm the public good.

The Brain on Psychedelics: Psilocybin vs Ketamine

The hypothalamus is a deep brain region that is crucial for regulating fundamental processes like mood, hunger, and stress. A recent study in the Journal of Psychopharmacology has investigated the effects of both psilocybin and ketamine on the rat hypothalamus. The researchers analysed changes in the production of brain messenger molecules (neuropeptides) after each drug was administered, finding some marked differences.

Psilocybin

A single high dose of psilocybin was seen to promote widespread changes in the hypothalamus. It increased the activity of a variety of neuropeptides involved in both mood and appetite. This suggests it has a rather broad effect on these signal pathways. Interestingly, it also decreased the production of one specific neuropeptide associated with appetite suppression – further evidence of a broad, wide-ranging effect on the brain. These findings offer some underpinning for how psilocybin might be used to treat conditions like depression or anorexia, by directly affecting the circuits that govern emotion and food intake.Ketamine

In contrast to psilocybin, ketamine’s effects were markedly more focused. They had a much more limited, targeted effect on neuropeptides in the hypothalamus. Ketamine is well known for its rapid antidepressant effects. This research suggests that while their therapeutic effects may have some perceived similarities, ketamine’s mechanism of action within this specific brain region is very different to that of psilocybin. Once again, this study highlights the importance of further research and understanding as it illustrates plainly that not all psychedelics affect the brain in the same way, even if they can produce similar outcomes, in combination with therapy.

Final Thoughts

The sheer volume of new research and policy updates of late shows just how rapidly the landscape of psychedelic medicine – and perception of psychedelics in all contexts – is evolving. There is immense and growing promise, but many difficulties and barriers to genuine progress persist. With cautious optimism, we will continue to monitor these developments as they unfold.