Medicinal
What we know about the effect of psychedelics on women’s health
Published
3 years agoon
By
News Editor
In this article, Nina Patrick, Ph.D. and Natasha Antropova, Ph.D., explore what the science says about psychedelics and women’s health, from hormones, depression and eating disorders to endometriosis, chronic pelvic pain, trauma and more.
Psychedelics are experiencing a renaissance. These mind-altering substances, which were once prohibited and criticized, are gaining attention again as potential remedies for various clinical problems.
The effectiveness of psychedelics has been documented by studies performed as early as the 1960s, and nowadays multiple clinical trials are underway to investigate the potential of psychedelic drugs such as ketamine, MDMA, and psilocybin mushrooms to treat various conditions, including depression, anxiety, substance abuse, post-traumatic stress disorder, eating disorders and many more. With these long-stigmatized substances making a comeback in the scientific realm, it is possible that women may see a particular benefit from them.
At present, there is a lack of understanding among scientists regarding how the pharmacology of psychedelic substances might impact a woman’s physiology. That is not surprising, since much of the past research in this area has focused on white male populations, and has left a significant gap in our understanding of how psychedelics may impact women’s health.
This presents a large opportunity for research to investigate how psychedelics may influence female-specific issues such as chronic pelvic pain, mood disorders, perinatal depression and even the challenges of motherhood.
Connection to hormones
Classic psychedelics work by activating serotonin (5-HT2A) receptors in the brain. Activation of the 5-HT2A receptors can lead to changes in mood and promote neuroplasticity, or the brain’s ability to change and adapt, which could be important to treating mental health disorders.
Serotonin is commonly associated with happiness and elevated mood, it is also involved in the modulation of pain from the brain to the spinal cord. While the mechanism is not fully understood, there is promising evidence that if you treat one of the domains of pain, anxiety, or depression, another may also improve.
The literature has also shown that female hormones, particularly estrogen, have intriguing interactions with the serotonin 5-HT2A receptor. Research has demonstrated that estrogen increases the density of 5-HT2A binding sites in areas of the brain responsible for mood, mental state, emotion, cognition and behaviour.
The relationship between estrogen levels and 5-HT2A binding sites may also provide clues to gender differences in psychiatric conditions like schizophrenia and depression, which are more common in women than men. Furthermore, disruption of estrogen levels during menopause may lead to dysregulation of the 5-HT2A and brain-derived neurotrophic factor (BDNF) signaling pathway, which could predispose the brain to depression.
Given that classical psychedelics, like psilocybin, MDMA and LSD, primarily elicit their effects via the 5-HT2A receptor, the presence, absence and combinations of female hormones could potentially enhance the effect of psychedelic compounds in women. However, the research on understanding the effects of psychedelics in the unique environment of the female body is still in its infancy.
Gender differences
Exploring gender differences in the effects of psychedelics is an important step toward making them clinically available. Various research groups in the field have looked into the effects of psilocybin on mental states and cognitive functions between male and female groups. Surprisingly, little variance was found.
A study published in June 2022 led by Zach Walsh’s research team at the University of British Columbia, Kelowna, aimed to assess the impact of psilocybin microdosing on mood and mental state. They followed 1133 individuals for two years, out of which 953 individuals engaged in their mushroom microdosing practice, and 180 individuals did not consume anything.
The individuals who microdosed mushrooms reported small to medium improvements in mood, anxiety and depression. Interestingly, no significant gender differences were found except for with depression, where women reported a higher improvement than men.
Furthermore, a separate study with rats given psilocybin found no disparities in decision-making and motivation, and no differences amongst male and female rates. Overall, these studies indicate that differences in the effects of psychedelics may not be significant between genders, but more studies are underway.
While no gender differences have been found yet, psychedelics do show promise as a clinical solution for certain disorders that are more prevalent in women. For instance, women are more susceptible to PTSD than men, and eating disorders such as anorexia nervosa are three times more common among women than men.
Let’s look at what we know so far.
Eating disorders
To date, several studies have investigated the effects of psychedelics on body dysmorphic disorder and eating disorders. The overall conclusion is that the efficacy of this treatment is unclear, but there is a lot of support and encouraging stories to warrant further exploration.
A Toronto-based group performed an extensive review of 372 studies using psychedelics for eating disorders performed before February 2022. While positive results were observed, they were mostly identified through thematic analysis and self-reports. These findings underscore the need for further exploration, which multiple groups are currently pursuing.
One group is the Multidisciplinary Association for Psychedelic Studies (MAPS), which is currently conducting a study on MDMA-assisted therapy with 36 participants suffering from anorexia, bulimia or binge-eating disorders. The Centre for Psychedelic Research at Imperial College London is also leading a clinical trial on psilocybin-assisted psychotherapy as a treatment for anorexia.
Premenstrual Dysphoric Disorder (PMDD)
Premenstrual dysphoric disorder (PMDD), a severe mood disorder, is characterized by mental health and physical symptoms in the week before the onset of menstruation and affects millions of women worldwide. It is a much more intense form of PMS.
Currently, the first line of treatment for PMDD are selective serotonin reuptake inhibitors (SSRIs). Unlike in other mood disorders, patients with PMDD experience rapid onset of action from SSRI (as opposed to the typical two to three week onset time). Other treatments include hormone therapy, psychotherapy and supplements such as calcium, vitamin B6 and magnesium.
Unfortunately, many women with PMDD do not respond to the traditional treatment options. Recent research shows that ketamine administered at the onset of PMDD may alleviate the treatment-resistance symptoms.
Ketamine is FDA-approved for use at high doses as an anaesthetic to put you asleep during surgery. Although not FDA-approved, lower doses that are “sub-anesthetic” are used “off-label” to treat depression, pain and other mental health and substance use disorders.
Recent data shows that ketamine actually activates estrogen receptors. This is important because declining levels of estrogen during the luteal phase may be a contribution factor to PMDD. By administering ketamine at the start of the luteal phase, or when symptoms of PMDD become apparent, it may be possible to treat one of the big contributing factors.
The same study showed that ketamine works with estrogen to increase glutamate levels. Glutamate is a neurotransmitter that may be uniquely connected to major depression. The lack of glutamate in certain regions of the brain has been strongly linked to depression.
Ketamine has been shown to activate glutamate transmission in the brain and is thought to be a key mechanism in its anti-depressant effects. Therefore ketamine may have a direct impact on mood and other signs of depression is administered at the onset of PMDD.
Endometriosis, chronic pelvic pain and trauma
Chronic pelvic pain affects 26% of the female population and is associated with negative cognitive, behavioral, sexual and emotional consequences which affect many aspects of a person’s life. Endometriosis is a component of 70 to 80% of the cases of chronic pelvic pain, and over 170 million women worldwide suffer from endometriosis.
Chronic pelvic pain is more severe in women with a history of physical or psychological abuse and mental illness. A study of over 60,000 pre-menopausal women found that women who reported severe sexual and physical abuse in childhood and adolescence had a 79% increased risk of endometriosis. The study suggested that early traumatic experiences affect the production of stress hormones and inflammatory responses that contribute to chronic pelvic pain and other pain symptoms.
Since serotonin is involved in the modulation of pain, anxiety, and depression, psychedelics which target the 5-HT2A receptor offer a hopeful prospect for women suffering from chronic pelvic pain, endometriosis and trauma.
At the moment, no clinical trials using psychedelics for endometriosis and chronic pelvic pain are currently listed on clinicaltrials.gov, which indicates an opportunity for research and development.
Psychedelics during pregnancy
Currently, there is a lack of clinical research on the effects of psychedelics during pregnancy. While some initial studies from the late 1960s and 1970s indicate that LSD use during pregnancy did not cause harm or congenital disability, these findings are not definitive and necessitate further investigation.
It is important to remember that the use of psychedelics during pregnancy is illegal due to the unknown impact on fetal development. Furthermore, certain psychedelics, such as LSD and mescaline, have shown the ability to provoke uterine contractions in animal studies.
Prenatal and postpartum depression
Depression is a common mental disorder among women before, during and after giving birth. Depression affects 6 to 12% of mothers in high-income countries and a larger population, 20 to 25%, of mothers in middle-income and low-income countries.
Studies have linked Cesarean sections (C-sections) to postpartum depression (PPD), which is related to reduced quality of parent-child interaction and adverse effects on maternal and child health. Cesarean section deliveries account for nearly 30% of births annually, and emergency C-sections account for 7 to 9% of all births.
Evidence is generally lacking for the use of psychedelics for pregnancy-related depression, however, due to the known safety profile of ketamine and its FDA-approval, it has been investigated for its use in prenatal and postpartum depression.
Prenatal Depression
In a collaborative effort between Peking University and the Outcomes Research Consortium in the USA, a small study was conducted to test the feasibility of ketamine use in prenatal depressive symptoms for the possibility of running a future large randomized trial.
A total of 66 women with prenatal depression who were scheduled for an elected cesarean delivery were randomized to receive either low-dose ketamine (0.5mg/kg) or placebo. The study drugs were administered intravenously over a 40-minute period after clamping the umbilical cord. Depression was assessed 48 hours postpartum.
The depression score did not differ between the groups, but the pain intensity was less severe at four hours postpartum in the ketamine group. Despite limited differences between the ketamine and placebo group on depression score, the study protocol demonstrated that it is feasible for a large randomized trial.
Postpartum depression
Ketamine was investigated for its effect on postpartum depression in women undergoing cesarean delivery. In a larger study of 654 women undergoing C-section, 10 minutes after childbirth, patients in the ketamine group were given a higher dose of ketamine, 0.5mg/kg, while the women in the control group were given standard postpartum care.
The prevalence of postpartum blues and postpartum depression were significantly lower in the ketamine group, and the study findings suggested that ketamine functions are a preventative agent against postpartum depression.
Psychedelics in motherhood
From the moment a child is born, a mother’s responsibilities grow exponentially. Her days become filled with the tasks of two people, mother and child, that require attention, care and patience. Despite the joy that motherhood brings, it can also be a stressful and overwhelming experience, exacerbated by the societal pressure on women to balance work and life, and essential “do it all.” Motherhood can leave mothers feeling drained and burnt out.
Microdosing psychedelics has emerged in recent years as a potential solution to alleviate some of the stress and anxiety of motherhood. While this approach is controversial, many mothers have reported positive experiences and benefits from microdosing. They claim that microdosing helped them manage their emotions, improve their mood and enhance their well-being.
A Colorado-based, nationwide group called Moms on Mushrooms (M.O.M), was created to teach interested moms about using a small dose of psilocybin mushrooms. The community has connected mothers who share and mirror each other’s struggles as a parent and has helped women feel comfortable enough to try microdosing.
Tracy Tee, the founder of M.O.M, told Rocky Mountain PBS: “I just really felt a calm and a space between my world that I hadn’t felt before. In the same way that you take an antidepressant, that’s what microdosing is.”
A majority of people using SSRIs, or prescription antidepressants, are women, and the World Health Organization has found major depressive disorder the leading cause of disease burden for women internationally.
Some mothers have reported that microdosing mushrooms has assisted them enough to slowly stop taking antidepressants or anti-anxiety medicines.
They say that taking a microdose, between 0.1 milligrams and 0.3 milligrams, taken over a period of days, gives them more patience, the ability to cope, more organizational talent and more happiness in the physically and emotionally difficult hours of raising children.
Many mothers also tout that a microdose of mushrooms is safer and less high-inducing than a glass of wine or beer. Many report that the microdoses are so small that they do not, or barely, register a “buzz.”
Despite these anecdotal reports of improvements, psilocybin and mushrooms remain illegal in a majority of countries and regions, but Colorado is progressive on this regulation. On November 8, 2022, Colorado passed the Natural Medicines Health Act which allows people 21 and older to grow and share psychedelic mushrooms.
Policy and progress
Psychedelic Medicines were predicted to be a gamechanger in 2023 by The Economist’s video The World Ahead 2023: five stories to watch out for. Policy reform around psychedelic therapies with the Natural Medicines Health Act in Colorado and Australia’s recent reclassification of psilocybin and MDMA to enable prescription are leading the way and setting the example for other countries to follow.
It is anticipated that MDMA-assisted therapy for the treatment of PTSD will pass FDA approval in late 2023 or early 2024, and in the next few years psilocybin is expected to be considered for FDA approval as well.
In November 2022, results from a Phase 2 psilocybin trial found that a single 25 milligram dose eased symptoms of depression for patients with treatment-resistant depression.
Although a few clinical trials have shown significant improvement for patients with certain mental health disorders, many early clinical trials, especially trials for women’s health issues are missing conclusive data on the benefits of psychedelics. There presents an opportunity for more research and development to meet these unmet needs and see if psychedelics can make an impact in women’s health.
Nina Patrick, Ph.D., is a biotech entrepreneur and content creator with expertise in psychedelics, drug discovery, diagnostics and longevity. You can reach her at Nina@ninapatrick.xyz.
Newsletter: www.notes.ninapatrick.xyz
Website: www.ninapatrick.xyz
Email: nina@ninapatrick.xyz
Twitter: @ninapatrick
Natasha Antropova, Ph.D., is an AI product manager at DeepMind and content creator with expertise in women’s health and AI. Please reach out at iam.natasha.antropova@gmail.com
newsletter: https://healthyhertech.substack.com
email: iam.natasha.antropova@gmail.com
twitter: @Natashantropova
LinkedIn: https://www.linkedin.com/in/natashaantropova
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2025 in Psychedelics: Big Pharma Entry, Patient Access in Germany, Czech and Australia, Governments Expand Conversation With Stakeholders
Published
3 months agoon
23rd December 2025
In 2025, the psychedelic medicine sector reached a more defined phase of maturity, as Big Pharma entry, late-stage clinical readouts, and incremental regulatory shifts began to reshape investor expectations, policy debates, and the direction of research across business, government, and academia.
Business and Investment
Big Pharma joins the sector as key companies push research goals forward
2025 saw pivotal corporate developments across the major psychedelic medicine companies, uplifting investor expectations and clarifying some regulatory pathways. A slow but steady loosening of regulatory hurdles and positive clinical results have breathed new life into the sector, with some analysts reporting refreshed investor interest and a possible end to the capital drought that has slashed the space in recent years.
Big Pharma giant AbbVie, known for blockbuster drugs in immunology and oncology, agreed to acquire Gilgamesh Pharmaceuticals’ lead experimental therapy, bretisilocin, in a deal reportedly worth $1.2 billion. Bretisilocin is a novel psychedelic targeting major depressive disorder. The event is a signal of Big Pharma entering the space and prioritising shorter-acting serotonin-2A modulators for depression.
Compass Pathways reached a major clinical inflection point, reporting positive results in its first Phase 3 COMP360 trial and accelerating commercial launch planning. CEO Kabir Nath recently told Psychedelic Health that positive talks with the FDA indicate that the company “could potentially be looking at a launch in early 2027” for its flagship program with synthetic psilocybin.
Beckley Psytech, which is supported by Atai Life Sciences secured a Breakthrough Therapy designation by the FDA for BPL-003, a novel intranasal formulation of 5-MeO-DMT, reinforcing regulatory momentum the compound known as “toad venom.” The FDA’s decision follows promising results from a Phase 2b clinical trial, which demonstrated that a single dose of the compound led to rapid and sustained reductions in depressive symptoms within 24 hours, with effects lasting up to eight weeks.
Cybin advanced multiple clinical programs, completing enrollment milestones for CYB004, a version of DMT targeting generalised anxiety disorder and maintaining progress on CYB003, a 5-HT2A receptor agonist similar to psilocybin for major depressive disorder. The company secured financing to extend runway and protect intellectual property across its portfolio.
MindMed reported faster than expected enrollment in its Phase 3 MM120 program, an analog of LSD targeting generalised anxiety disorder, updating timelines for topline readouts and emphasising oral LSD analogs as a differentiated regulatory route.
Policy and Regulation
Major global players reschedule psychedelics for medical use
2025 marked a year of uneven but consequential movement in psychedelic policy and regulation, with a small number of jurisdictions taking concrete steps toward medical access while others remained in exploratory or preparatory phases.
The UK’s regulatory landscape for psychedelic medicine continued to evolve through policy dialogue and research initiatives, although no formal legalisation or medical scheduling changes occurred. The Royal College of Psychiatrists published a position statement reviewing evidence on psilocybin, MDMA, LSD, and ketamine, concluding that current data are promising but insufficient to recommend routine clinical use outside licensed settings, emphasising the need for more robust trials and caution against premature adoption.
This year, the UK government agreed in principle with key Advisory Council on the Misuse of Drugs (ACMD) recommendations to ease barriers to Schedule 1 psychedelic research. Part of the recommendations included allowing universities and hospitals to conduct research without a Home Office domestic licence, and ethically approved clinical trials to be exempt from additional licensing. Though these changes are not in effect yet, they could be enacted after a pilot program takes place.
Australia continued to stand out as a global pioneer in medical access. Since 1 July 2023, MDMA and psilocybin have been rescheduled from strictly prohibited status to controlled medicines, meaning authorised psychiatrists can legally prescribe them for treatment-resistant depression and post-traumatic stress disorder. From 6 January 2025, new quality standards for MDMA and psilocybin products came into force, requiring compliance for all supplied APIs and finished products. The Department of Veterans’ Affairs approved funding for psychedelic-assisted psychotherapy for eligible veterans, marking a first step toward public payer support.
In Europe, Germany became the first EU country to establish a formal compassionate use access programme for psilocybin, enabling adults with treatment-resistant depression to receive psilocybin therapy at specialised centres under a regulated framework prior to full regulatory approval. This initiative, supported by the German Federal Institute for Drugs and Medical Devices and implemented at facilities in Mannheim and Berlin, marks a landmark step in European psychedelic policy.
The Czech Republic is set to become one of the first European countries to legalise medical use of psilocybin from January 1, 2026. The outgoing government approved legislation late in 2025 allowing psychiatrists and psychotherapists to administer psilocybin for conditions such as cancer-related depression and serious clinical depression when other registered treatments have failed or are not tolerated. Psilocybin therapy will be introduced under controlled clinical conditions at qualified facilities.
In the United States, action remained at the state-level. Oregon and Colorado, having already legalised regulated access to natural psychedelics including psilocybin and launched supervised service programs, continued to refine implementation and data collection frameworks in 2025. Meanwhile, numerous state legislatures introduced bills to advance psychedelic therapy access, and Massachusetts held legislative hearings on psychedelic therapy programmes, reflecting growing political engagement despite the absence of federal reclassification.
Science and Research
New data from real-world applications and feedback from regulatory agencies inform research
In the academic side of the equation, 2025 consolidated a transition from exploratory efficacy signals to confirmatory, regulation-relevant evidence, while underscoring persistent limitations: small sample biases, variable control conditions, and unresolved questions about long-term safety and scalability.
One of the most significant published findings came from a phase 2 trial in cancer patients, where a single dose of psilocybin combined with therapy produced sustained reductions in depression and anxiety, with many participants maintaining benefits up to two years later.
Alongside observational outcomes, mid-stage clinical studies have found LSD may ease anxiety symptoms for up to three months in people with moderate-to-severe generalised anxiety disorder, with a significant proportion of participants still in remission at 12 weeks.
For the first time, data from real-world application of psilocybin treatment under a regulated program was published by one of the Oregon clinics providing treatment, sharing insights into how the legal, real-world version of the treatment works, who can access it, and whether the benefits observed in trials translate to broader populations.
Longitudinal data strengthened claims of sustained benefit in selected cohorts. Multiple follow-up reports published in 2025 described durable antidepressant effects at extended intervals after single or limited psilocybin administrations, although most samples remained small and non-randomised. These findings have prompted calls for larger, controlled long-term studies.
The FDA’s public release of the complete response letter on Lykos Therapeutics’ trials on MDMA therapy highlighted durability and safety questions, prompting re-examination of trial design and participant selection in MDMA and related programmes.
Cambridge Psychedelic Research Group formally launched in 2025, creating a new hub for clinical trials and interdisciplinary research in the UK, including pathways for patient recruitment and academic-industry collaboration.
Illustrated image made using AI tools.
Markets & Industry
Netflix Premieres New Documentary on Ibogaine as Ambio Launches Europe’s First Physician-led Ibogaine Facility
Published
4 months agoon
7th November 2025
Ambio Life Sciences, a company known for its physician-led ibogaine therapy programmes, has been thrust into the global spotlight with the release of In Waves and War on Netflix, a documentary filmed at one of its treatment facilities, while simultaneously announcing the opening of its first European clinic in Malta.
Ambio is a clinical organisation that offers medically supervised ibogaine programmes focused on trauma recovery, neuroregeneration and substance use disorders. The company’s leadership will be part of PSYCH Symposium: London 2025, occurring at London’s Conway Hall on December 4.
In Waves and War
The new Netflix documentary follows several former U.S. Navy SEALs as they confront the psychological and neurological scars of combat, including post-traumatic stress and traumatic brain injury, through ibogaine-assisted therapy. Filmed partly at Ambio’s clinic in Mexico, the film presents a rare, direct view of what such treatment entails and how it fits into the broader debate about the role of psychedelics in addressing mental health and substance use disorders.
In the film, Ambio showcases a clinical model that departs from the underground or informal settings that have long characterised ibogaine use. The company’s approach, grounded in medical oversight and structured aftercare, contrasts sharply with earlier practices and aligns with emerging calls for regulated, evidence-informed psychedelic care.
Ambio Life Sciences CEO and Co-Founder Jonathan Dickinson said to Psychedelic Health that the film’s timing is both urgent and consequential. “It is now 24 years after the start of the Global War on Terrorism, and rates of veteran suicide continue to rise. This film is being released to a global audience at a crucial time. The good news is, ibogaine is uniquely capable of addressing the intersection of mental health challenges, neurocognitive injury, and substance use,” he said. “Over the past five years, ibogaine in Mexico has quietly become the treatment of choice for the operator community, many describing immediate and lasting relief, often after years of failed conventional treatments.”
The documentary also foregrounds patient voices. Retired Navy SEAL and Ambio patient DJ Shipley, one of the film’s central figures, described his experience: “Ibogaine allowed me to become a better, more well-rounded version of myself, someone with more empathy, more compassion, but without losing my edge. I’m incredibly proud of my castmates and the directors. They did a beautiful job telling our story. I truly hope this film changes lives and helps people find strength in its vulnerability.”
The New Malta Clinic
Alongside the film’s debut, Ambio announced the launch of its new clinic in Malta, described as Europe’s first physician-led ibogaine facility. According to the company’s release, the centre offers a structured residential programme that combines medical screening, 24-hour physician supervision and integrated therapeutic support. Treatments will take place in a medically equipped environment with on-site emergency protocols, a full-time medical team, and facilities designed for private accommodation and holistic therapies such as breathwork and somatic work.
The Malta site marks Ambio’s first expansion beyond North America and establishes a strategic base for patients from Europe, Canada and the eastern United States. By creating a clinic that operates under formal medical oversight, Ambio seeks to raise safety standards and expand accessibility in a field that has often been criticised for its lack of regulation.
Ambio Life Sciences, founded by clinicians with experience treating addiction and trauma through ibogaine, positions itself as a provider of evidence-based, medically supervised psychedelic care. The company’s work has focused on neuroregenerative and trauma-related conditions, with a particular emphasis on veterans and first responders.
The combination of global media exposure and clinical expansion underscores Ambio’s role in shaping the public perception and practical delivery of ibogaine treatment. As both scrutiny and interest in psychedelic medicine intensify, Ambio’s visibility through In Waves and War and its new European operations will test how far the treatment can move toward mainstream medical acceptance.
Picture courtesy of Ambio Life Sciences.
Evegreen
Psilocybin Shows Promise in Treating Obsessive-Compulsive Disorders: Is the Industry Getting Involved?
Published
4 months agoon
30th October 2025
A newly published systematic review titled on psilocybin’s effects on obsessive‑compulsive behaviours provides an up-to-date synthesis of research into the compound’s potential for treating OCD and related disorders.
The study integrates findings from both animal models and early human trials, drawing attention to a consistent signal: reductions in obsessive or compulsive behaviours following psilocybin administration.
The review shows that in preclinical models (for example mice with altered grooming behaviours) psilocybin (or its active metabolite) produced marked reductions in compulsive-like behaviours, sometimes lasting beyond the immediate administration period.
Clinically, although data remain limited, participants in early trials or case reports experienced rapid reductions in symptom severity (for example within hours or days) after single doses. The authors emphasise that while the mood-disorder applications of psilocybin are more advanced, this compulsive-behaviour indication is an important frontier.
In humans, single doses of psilocybin led to rapid symptom reductions. For example, in an open‑label study of nine treatment‑resistant OCD patients, reductions of 23 % to 100 % on the Y‑BOCS scale were recorded between 4 and 24 hours after dosing. A pilot trial in body dysmorphic disorder (a related OCRD) using a 25 mg psilocybin dose reported sustained improvements over 12 weeks in 58.3 % of participants.
Mechanistically, the review highlights that psilocybin’s effects on compulsivity may not map exactly onto its classic psychedelic mechanism (5-HT₂A receptor activation). Some animal data suggest alternate or additional pathways (for instance 5-HT₇ receptor involvement, synaptic protein modulation) may underpin the anti-compulsive outcomes. The authors call for more robust, placebo-controlled human trials, ideally with neuroimaging and circuit-level biomarkers, to validate these early signals and clarify therapeutic protocols.
The authors of the review emphasise that while the findings are promising, the evidence remains early stage. Key limitations include small clinical sample sizes, lack of placebo‑controls, short follow‑up intervals and heterogeneity in doses and models. They call for larger, double‑blind, placebo‑controlled trials incorporating neuroimaging of fronto‑striatal circuits, to more precisely map psilocybin’s effect in OCRDs.
The authors propose that psilocybin may one day serve as a treatment for disorders characterised by repetitive, intrusive behaviours, not just mood disorders.
Are companies developing psilocybin-based treatments for OCD?
Several biotechnology companies are advancing psilocybin-based therapies for obsessive-compulsive disorder (OCD), signalling growing clinical interest in this area.
Ceruvia Lifesciences has received U.S. FDA approval for an Investigational New Drug application to begin a Phase 2 trial using its synthetic psilocybin compound, SYNP-101, for OCD. The multicentre, randomised, double-blind, placebo-controlled study will administer a single oral dose and monitor participants for 12 weeks to assess symptom reduction, making it one of the most advanced OCD-focused psilocybin programmes.
Filament Health is developing PEX010, a botanical psilocybin drug exported to Israel for a trial investigating treatment-resistant OCD and PTSD.
MycoMedica Life Sciences lists OCD among its target indications, though its programmes remain early stage, while Compass Pathways is exploring broader psychiatric uses for COMP360, including potential applications in OCD.
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