More than 5 million Americans would be eligible for psychedelic therapy, study finds

As the FDA reviews psilocybin-assisted therapy, Emory’s real-world analysis depicts the public health demand and economic impact based on medical eligibility

Emory Health Sciences

 

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Fayzan Rab, MD candidate, psychedelic researcher, and lead author of the study

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Credit: Emory University

Acupuncture. Ketamine infusions. “Electroshock” or electroconvulsive therapy. The existing treatment options for those diagnosed with Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD), may sometimes feel daunting or expensive alternatives to medication. However, a groundbreaking study from Emory University demonstrates how psilocybin-assisted therapy could impact more than 5 million people in the U.S. pending approval from the FDA.

The findings highlight both the national need for therapies featuring psilocybin, the active ingredient in hallucinogenic mushrooms, as well as the considerations that elected officials, insurance companies, and public health agencies would need to be aware of to successfully roll-out access to psilocybin-assisted therapy (PSIL-AT). 

In the study, researchers used national data from the existing pool of people being treated for MDD and TRD, and applied exclusionary criteria based on comorbidities, such as mania, heart failure, and diabetes, to rule out those who would be medically ineligible for the therapy. These findings indicate that anywhere from 56 to 62% of the individuals being treated for MDD and TRD— roughly 5.1 to 5.6 million people—would be eligible for PSIL-AT and could benefit from it.

“This information is significant because much of the current focus on psychedelic therapies is about its efficacy within clinical trials, and very few people are studying what would be the broader implications of implementing these novel therapeutics,” says Fayzan Rab, lead author of the study and M.D. candidate at Emory University’s School of Medicine. “Our study is one of the first to look at the bigger public health and economic consequences of a world where psilocybin therapy is made more available to Americans.” 

According to Rab, psilocybin-assisted treatment currently has a breakthrough designation with the FDA, meaning that it will expedite a review of the Phase III clinical trial results because of its potential as a therapeutic for depression.

“What is really timely about this research is that it provides a data-driven number that is interpretable to the FDA,” says Rab. “This is how many Americans we think are at stake. I think that will be a meaningful estimate for the FDA to weigh when they consider whether to approve psilocybin for therapeutic use.” 

If approved, private and public insurers such as the Centers for Medicare & Medicaid Services will shape both the demand and the availability of psychedelic therapy. According to the study, almost 20% of the 85 million Medicaid beneficiaries—or 17 million people – are likely to have clinical depression. Therefore, the conditions under which Medicaid might or might not reimburse for psilocybin-assisted therapy will determine the demand.  

A psycho-spiritual model to bring patients to a state of spiritual and mental wellness

An additional prominent attribution to the study is that it is supported by Emory University’s Center for Psychedelics and Spirituality(ECPS), which integrates clinical and research-backed expertise in psychiatry and spiritual health to better understand the therapeutic value of psychedelic medicines. 

George Grant, MDiv, PhD, and co-director of the ECPS, emphasizes that the public health forecast in Rab’s study provides policymakers with an idea of the economic impact, as well as if the treatment will meet the needs of the underserved. 

“Coming to the aid of people who are suffering is very important, and psilocybin-assisted therapy could help people arrive to a place of satisfaction within themselves so that their lives achieve optimal meaning and purpose,” says Grant, also the executive director for Spiritual Health at the Woodruff Health Sciences Center. Regarding the economic impact on the healthcare system, Grant adds, “Psychedelic medicines have promise because the intervention is so fast acting, whereas right now, insurance providers and payers often need to fund the use of antidepressants throughout their lives.” 

Grant is referring to past clinical trials studying the efficacy of psilocybin, which indicate that just one singular 25 mg dose of psilocybin is often enough to reduce symptoms of depression—potentially decreasing the financial burden on insurance payers currently funding other interventions. 

“I am glad to be supported by the Center for Psychedelics and Spirituality, which is an academic environment, providing an objective third-party perspective to policymakers, the FDA, and public health agencies,” says Rab, emphasizing that the study was not done in conjunction with any pharmaceutical agencies. “I am really hopeful that continued research in the area of psychedelic medicine and therapeutics could benefit the millions of Americans that might qualify for it.” 

CITATION: Rab, Syed Fayzan et al. An estimate of the number of people with clinical depression eligible for psilocybin-assisted therapy in the United States. Genomic Press Psychedelics. 13 September 2024.

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Method of Research

Data/statistical analysis

Subject of Research

Not applicable

Article Title

An estimate of the number of people with clinical depression eligible for psilocybin-assisted therapy in the United States

Canada should be ‘world leader’ on alternative PTSD therapies, veteran says

By Sean Boynton Global News
Posted November 10, 2024

WATCH: After being injured in Canada's longest, most expensive war effort, one veteran created and fundraised an exhibit to help ensure the efforts of those who served — and the memories those who died — aren't forgotten. Mercedes Stephenson explains  

A Canadian Forces veteran who served in Afghanistan says Canada should be a “world leader” on alternative therapies for treating veterans’ post-traumatic stress disorder and other post-combat trauma, including the use of psychedelics.

Retired MCpl. Gordon Hurley says psychedelic treatments such as ketamine and psilocybin, or “magic mushrooms,” can give veterans “a breath of relief” from their trauma or addictions, pointing to his own experience, and is calling for further study and coverage for physician-assisted therapies.

“I really think we’re in a unique position as a country, with such a liberal view on health care and life, that we should be able to be a world leader in providing alternative therapies,” he told Mercedes Stephenson in an interview that aired Sunday on The West Block ahead of Remembrance Day.

“We should be doing the same thing with our veterans just how you send us to war. A majority of the time we’re saying, ‘Send me, send me.’ We can do the same thing with these types of treatments.”

Hurley deployed to Afghanistan in the summer of 2008, just 15 months after joining the military and completing basic training. He was injured by an improvised explosive device but returned to the battlefield just three weeks after surgery.

2:21

Nova Scotia company to examine magic mushrooms as PTSD treatment



More than 40,000 Canadians served in Afghanistan, many on multiple tours during the 20-year global War on Terror, and 165 Canadian Armed Forces members died there.

Many veterans of that war returned to Canada suffering not just from PTSD but also traumatic brain injuries and effects from toxic burn pit exposure, among other traumas.

Research has suggested recent veterans have had a higher rate of mental health and addiction issues compared to older veterans and the overall Canadian population.

Veterans Affairs Canada is conducting research and clinical trials into the use of ketamine as a treatment for traumatic brain injuries and depression, but has yet to launch a similar project on psilocybin. Independent studies have been launched across Canada in recent years into psychedelic treatments

A Senate committee report last December urged the federal government to “immediately” conduct a “major research program” into how psychedelics can help veterans suffering from PTSD. The report said research already exists into the effectiveness of such treatments and warned Canada is falling behind other countries in studying them.

The United States has funded research into psychedelic treatments for veterans, but the U.S. FDA this year rejected an approval for MDMA treatment, calling for further study.

Briefing notes prepared for the veterans affairs minister last year say the department only provides financial coverage for treatments that are supported by solid research, and says approved psychological and psychiatric treatments are the “first-line evidence-based” approach to treating PTSD and other mental issues.

2:01

Psychedelics approved for medical use in Canada

“Western treatment is completely fine,” Hurley said. “There’s nothing wrong with prescription drugs or SSDIs (antidepressants), whatever is going to work to get that person off the ledge is worth it. But there are other treatment options.”

Hurley said he travels to Mexico to receive treatment through psychedelics through a clinic run by Canadian doctors, and touted their effectiveness.

Besides psychedelics, Hurley also pointed to a treatment known as stellate ganglion block, which numbs nerves in the neck and “basically resets your nervous system,” he said. The treatment has been studied at multiple Canadian hospitals and universities and has been called “miraculous” in treating PTSD.

“To get that initial breath and that initial pause where they don’t have the cravings for their addiction, or they don’t have the annoyances of trauma, of post-traumatic stress, of perhaps being too freaked out to go into public spaces or noises and all these other detriments to the veteran’s life … we could be fixing with different types of treatment,” he said.

Hurley said the government should particularly cover assisted treatment programs that allow doctors to work with patients and ensure veterans are taking the proper treatments and dosages.

“The doctor is going to have specific training to deal with psychedelics and how that integrates into a person’s life,” he said.

“We’re so new to it. It’s not anyone’s fault, but we should really be ahead of the curve on this.”

Psychedelic therapy provides hope for veterans

Story by Maya Goldman


Psychedelic therapy provides hope for veterans

Veterans are campaigning to take psychedelic therapy for post-traumatic stress disorder mainstream, despite the Food and Drug Administration's rejection of an ecstasy-based therapy in August.

Why it matters: About 29% of veterans who fought in Afghanistan and Iraq will have PTSD at some point in their lives, according to the Department of Veterans Affairs. Veteran suicide rates are also higher than in the general population.

"The thirst is very palpable among our generation" of veterans for alternative mental health therapies, Allison Jaslow, CEO of Iraq and Afghanistan Veterans of America, told Axios.

Catch up quick: Psychedelics like magic mushrooms, LSD and ecstasy can alter a person's state of mind and cause hallucinations.
It's been nearly impossible to research their effects, because they've been criminalized and classified as controlled substances since 1970.
But interest in psychedelics' potential to treat mental health conditions — particularly in veterans — has grown in recent years.
The FDA in 2017 granted fast-track review of a PTSD treatment that mixes ecstasy with talk therapy.

The VA started funding research into psychedelic therapies this year. Congress also passed bipartisan legislation directing the Pentagon to study the treatments.
In the meantime, more than 1,200 veterans traveled to other countries for psychedelic therapies through one nonprofit alone, said Jesse Gould, founder of that organization, Heroic Hearts Project.

But the FDA in August rejected the therapy it had originally fast-tracked, following an independent review that highlighted concerns like missing safety data and allegations of misconduct in clinical trials.

Zoom in: The decision felt like a major setback to veterans.
"It was emotionally just gut-wrenching, thinking about all of those veterans, and all the other people, for that matter, that were just really counting on being able to access this as a solution for their debilitating PTSD," said Juliana Mercer, a Marine Corps veteran and director at veterans advocacy group Healing Breakthrough.
The FDA rejection pushes mental health progress back years, added Gould, a former Army Ranger. It "indicates to veterans that they are not being listened to and they're not a priority."

Where it stands: Veterans are continuing to work toward broadening access to psychedelic therapies.
State-level action is also picking up. Oregon and Colorado have legalized psychedelic mushrooms for therapeutic use. But Massachusetts voters last week rejected a ballot proposal to legalize psychedelics.

What's next: The company behind the rejected ecstasy-based therapy now has a new acting CEO and chief medical officer, and it announced last month that it will run a new clinical trial on the PTSD treatment.

The VA has reportedly said it would consider funding the trial.
The FDA also fast-tracked review for a psychedelic mushroom therapy, though the company running that trial announced recently that it's delaying a key data release.

The new clinical trials will likely take at least two more years, Mercer predicted.
But the extended timeline means the VA "is going to be more prepared to effectively roll out a psychedelic program," she said. "I'm choosing to look at that as a silver lining."

Smoking toad venom helps veterans with PTSD, addiction, and depression

Allan Rose Hill
Mon Nov 11, 2024
BOING!BOING!


image: Deep Desert Photography/Shutterstock (manipulated)

Zach Skiles is a veteran and clinical psychologist who, informed by his own experiences, is helping other veterans deal with PTSD, depression, and drug addiction. As a researcher with University of California at San Francisco, Skiles leads veterans through psychedelic experiences to help alleviate some of their suffering. The participants are first given ibogaine—a natural stimulant with psychedelic properties found in the West African shrub iboga. After a long "group healing" session, they are administered 5-MeO-DMT, an extremely powerful and short-lasting psychedelic found in the venom of the Sonoran Desert toad. (Both compounds can also be synthesized in a laboratory.) Unfortunately. both of these compounds are illegal in the United States so the veterans must travel to Mexico for the actual treatments. In honor of Veteran's Day, the always-excellent Microdose republished Jan C. Hu's 2021 interview with Skiles:

What aspects of psychedelic therapy might help treat veterans in particular?

In treating PTSD, psychedelics enhance your ability to bring up trauma and simultaneously see it from different angles. Everything feels new, more revelatory and connected. There's the ability to take a step back and experience something in a totally new way.

One of the cooler things about psychedelic assisted therapies is you're not only getting those cognitive pieces, but you're also getting somatic, cathartic experiences at the same time. For people who've experienced sexual assault or combat exposure, you cut off a lot of sensation from your body and reconnecting to it is actually one of the main goals of all therapies. Having that experience along with these cognitive pieces is something that they call a codex condensed experience — it's happening in different constellations of the mind and body[…]

These therapies aren't legal in the U.S. What drove you and other vets to seek out these experiences in Mexico?

There's a bit of desperation; people have to leave the country to be able to get these therapies. These are folks who have spent careers in the U.S. Special Forces, with blast injuries or lesions on their brain. It's a group of folks who have tried every single therapy that's offered in the United States and have come up wanting more. They had to leave the country in order to have a therapeutic experience, and not be arrested for it.

It's important to give guys an ability to have the most up to date therapeutic access, but in the U.S.; it's also important for this to become regulated. We operate in the underground because that's the only place we can do this kind of thing.

Previously:
• FDA denies approval of MDMA-assisted therapy for PTSD
• These psychonauts are in training to take DMT trips that last hours or even days and report back… for science
• 'Please refrain from licking' toads, says National Park Service in unusual warning

 

Healing, spiritual purposes drive many veterans’ use of psychedelics

In survey, 85% of veterans report they benefited from the experience

Ohio State University

COLUMBUS, Ohio – Most U.S. military veterans who have used psychedelics reported in a recent study that they pursued the substances for healing or spiritual exploration, and over 80% said they benefited from the experience – even those who had challenging outcomes.

The survey also indicated many of the veterans would be more likely to seek mental health care, or return to care, at the U.S. Department of Veterans Affairs (VA) if psychedelic-assisted therapy were offered.

Findings from this comprehensive examination of veterans’ experiences with psychedelics can give clinicians a clearer understanding of the veteran community’s expectations and specific needs for mental health care, researchers say.

“Because of all of the complexity that veterans are experiencing and the higher risk they’re at for experiencing not just one, but several mental health and physical health-related challenges, it makes sense that they would be searching for opportunities to address those challenges, especially when they feel like they’re not being met with the current system here in the U.S.,” said lead author Alan Davis, associate professor and director of the Center for Psychedelic Drug Research and Education at The Ohio State University College of Social Work.

The study was published recently in the Journal of Psychoactive Drugs.

The VA estimates that more than 17 U.S. veterans die by suicide each day, according to 2021 data. And studies suggest between 44% and 72% of veterans are highly stressed during the transition from military to civilian life.

The research team, which included veterans, consulted with other past military service members to design a survey examining patterns of psychedelic use, perspectives of those who did and did not report use, and what kinds of benefits and adverse outcomes were associated with veterans’ use of the drugs. Veterans were referred to the survey through online advertisements and communities, email invitations and word of mouth.

“Understanding military veteran culture is crucial for civilian therapists working with this population,” said co-author Mark Bates, a retired U.S. Air Force pilot and clinical psychologist at Sunstone Therapies, a Maryland treatment center researching psychedelic-assisted therapies.

“It’s about avoiding inadvertently undermining the therapeutic relationship and knowing how to use military culture as an effective frame of reference. This is also part of the reason of why we carefully consulted with a team of veteran advisers in the development and validation of the survey questions.”

With veteran advocacy for access to psychedelic-assisted therapy increasing in recent years, Bates said, “There is a really pressing need to explore anything that’s promising for mental health treatment.”

The survey sample consisted of 426 participants categorized into two groups – those who had (217) and had not (209) used psychedelics. Drugs used by veterans included psilocybin (magic mushrooms), LSD, ketamine, MDMA (ecstasy), ayahuasca, ibogaine, 5-MeO-DMT (toad) and peyote/mescaline. The most commonly reported reasons for use were healing or treatment (69%), spiritual exploration (47.5%) or recreation (38.7%).

Compared to veterans who had not used psychedelics, the veterans who had taken the drugs were more likely to be older and had spent more time deployed during their service, and a larger proportion of them reported PTSD, depression and anxiety.

While some participants were alone when they used psychedelics, many reported taking them in spiritual locations or outdoors, with friends, or in medical clinics or retreat centers – both in the United States and abroad.

Overall, participants rated the psychedelic experiences as beneficial whether they considered the experience uniformly positive (88.6%) or endured one or more adverse outcomes (81.3%). The most common adverse outcomes were flashbacks and craving or trying to reduce use of psychedelics. Fewer participants reported being arrested or seeking medical treatment in relation to using the drugs.

Statistical analysis identified a number of factors that lowered the likelihood of having negative outcomes: being older, using psilocybin, having depression or anxiety, obtaining psychedelics from a safe source, being prepared, comfortable and confident during the treatment, and being able to trust, let go and be open to the experience.

“This finding highlights the importance of people in the veteran community knowing that keeping these things in mind prior to use can help set them up for the best possible outcome,” Davis said.

With most psychedelic substances classified as Schedule I drugs under the Controlled Substances Act, the only legal way for most people to access them in the United States currently is in a clinical trial setting. Davis is leading a current psilocybin-assisted therapy study at Ohio State for the treatment of PTSD among military veterans, and Bates and colleagues at Sunstone Therapies have treated many veterans to date.

Finding that surveyed veterans would welcome a chance to access psychedelic-assisted therapy at the VA is an important highlight of the study, the researchers said.

“What’s really exciting about this study and understanding veterans’ interest in psychedelic-assisted therapy is it’s potentially opening up an opportunity to address some of their core challenges head-on,” Davis said. “Veterans are dying by suicide and fleeing the country to find these opportunities in other places, so the message is clear. This needs to be available.”

Additional co-authors were Nathan Sepeda, Adam Levin and Stacey Armstrong of Ohio State; independent researcher Erik Lund; Robert Koffman of Sunstone Therapies; Katinka Hooyer of the Medical College of Wisconsin; and Rachel Yehuda of the Icahn School of Medicine at Mount Sinai.

This work was supported by private donors, the Cammack Family Gift Fund, the Center for Psychedelic Psychotherapy and Trauma Research at the Icahn Medical School, the Johns Hopkins Center for Psychedelic and Consciousness Research, and the CPDRE at Ohio State.

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Journal

Journal of Psychoactive Drugs

DOI

10.1080/02791072.2024.2401977 

Method of Research

Survey

Subject of Research

People

Article Title

The Epidemiology of Psychedelic Use Among United States Military Veterans

 

Psychedelic drug psilocybin changes brain connectivity to treat body dysmorphic disorder

Columbia University researchers uncover how a single dose of "magic mushrooms" changes brain connectivity to alleviate symptoms of the devastating mental illness

Genomic Press

 

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Whole brain multivariate pattern analysis (MVPA) reveals that seed brain regions including the thalamus [8 -6 8] (yellow), insula [-42 8 -6] (green), inferior parietal lobe (IPL) [-54 -38 38] (red), and ACC [16 34 24] (blue) predicted symptomatic improvement of body dysmorphic disorder (BDD) at one week following a single dose of psilocybin. Using these clusters as seed regions, no further regions were identified. 

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Credit: Xi Zhu, Columbia University, New York, NY

New York, NY - Body dysmorphic disorder (BDD) is a debilitating mental illness characterized by an obsessive preoccupation with perceived flaws in one's physical appearance. Patients with BDD often have distorted self-image, intrusive thoughts, and compulsive behaviors that significantly impair daily functioning and quality of life. Current therapies have limited efficacy, leaving many sufferers without relief.

A new study led by researchers at Columbia University and published in Psychedelics (Genomic Press, New York, USA) provides hope by revealing how the psychedelic drug psilocybin, the active ingredient in "magic mushrooms," may rewirechange connectivity of brain circuitry, potentially aiding in the treatment of this debilitating disorder.

In the pilot trial, eight adults with moderate-to-severe BDD that had not responded to standard treatments received a single 25mg oral dose of psilocybin in a supportive setting. Using cutting-edge functional MRI technology, the scientists scanned the participants' brains one day before and one day after the psilocybin session. Sophisticated pattern analysis techniques were then applied to map changes in brain network connectivity and link them to subsequent clinical outcomes.

The results were striking: Just one day after psilocybin administration, the patients exhibited increased connectivity both within a network governing executive functions, and between this network and others involved in processing emotionally salient stimuli and self-referential thinking. Notably, those who showed the greatest strengthening of these neural connections also experienced the most improvement in BDD symptoms one week later.

While preliminary, the findings align with a growing body of evidence indicating that psychedelic compounds like psilocybin can promote mental health by enhancing the brain's capacity for flexibility and integration. By facilitating communication within and between brain networks that are often dysregulated in psychiatric disorders, psilocybin may help restore more adaptive cognitive and emotional functioning.

As the first study of psilocybin in a BDD population, the trial was small and lacked a placebo control. The researchers caution that larger, placebo-controlled studies are needed to verify the efficacy and durability of the treatment. Still, the robust brain-behavior relationships uncovered bode well for the ongoing development of psilocybin therapy.

The peer-reviewed study, "Single-Dose Psilocybin Alters Resting State Functional Networks in Patients with Body Dysmorphic Disorder," will be published on September 24, 2024, in Psychedelics. It is freely available online at https://pp.genomicpress.com/aop/.

About Psychedelics – Psychedelics: The Journal of Psychedelic Pharmacology (ISSN: 2997-2671) is a peer-reviewed journal published by Genomic Press, New York. The journal is exclusively dedicated to the latest advancements in the realm of psychedelic substances and their potential therapeutic uses. Psychedelics embraces the full spectrum of research, from fundamental investigations to cutting-edge clinical studies and welcomes diverse perspectives and contributions, advancing the understanding of psychedelic compounds.

Contact: Chen Zhang, Columbia University: Chen.Zhang@nyspi.columbia.edu

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Method of Research

Experimental study

Subject of Research

People

Article Title

Single-Dose Psilocybin Alters Resting State Functional Networks in Patients with Body Dysmorphic Disorder

Article Publication Date

24-Sep-2024

COI Statement

Dr. Schneier has received research support from Compass Pathways, Otsuka, Vistagen, and NIMH, royalties from UptoDate, Cambridge University Press, and Guilford Press, and served as consultant to Receptor Life and PureTech. Dr. Hellerstein has received research support from Compass Pathways, Relmada, Intracellular Therapies, Beckley Foundation, serves on the scientific advisory board for Reset Pharmaceuticals and has received royalties from Johns Hopkins University Press and Columbia University Press. Dr. Feusner receives research support from the NIMH, NIBIB, and the Klarman Family Foundation and serves as a consultant to NOCD, Inc. Drs. Wheaton, Zhu, and Ms. Chen and Ms. Gomez have no financial relationships to report. This research was supported by a grant from Compass Pathways PLC, United Kingdom. Compass supplied materials and participated in formulating the outline of the study but had no role in study selection or interpretation of the evidence.

Psilocybin may curb mental illness linked to eating disorders

By Dennis Thompson, 

Sept. 24, 2024 

HealthDay News


Psilocybin could help people suffering from a mental health problem that can lead to eating disorders, a new study suggests. Photo by Adobe Stock/HealthDay News

Psilocybin could help people suffering from a mental health problem that can lead to eating disorders, a new study suggests.

Psilocybin, the active chemical in "magic" mushrooms, significantly reduced symptoms in people with body dysmorphic disorder (BDD), researchers reported Tuesday in the journal Psychedelics.

BDD causes an obsessive preoccupation with perceived flaws in one's physical appearance, and is frequently tied to eating disorders and other unhealthy behaviors, researchers said.

For this pilot trial, eight people with hard-to-treat BDD received a single 25-milligram dose of psilocybin.

Brain scans showed that the psilocybin treatment increased levels in connectivity between different brain regions related to emotional processing, cognitive activity and feelings and thoughts about oneself.

People who had the greatest strengthening in these connections experienced the most improvement in their BDD symptoms within a week, results show.

The findings "align with a growing body of evidence indicating that psychedelic compounds like psilocybin can promote mental health by enhancing the brain's capacity for flexibility and integration," concluded the research team led by Chen Zhang, a research assistant with the New York State Psychiatric Institute.

"By facilitating communication within and between brain networks that are often dysregulated in psychiatric disorders, psilocybin may help restore more adaptive cognitive and emotional functioning," the research team said in a journal news release.
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However, more studies in larger groups of people with BDD are needed to verify the effectiveness of the treatment and how long it will last, the researchers noted.

More information

Johns Hopkins Medicine has more on psilocybin therapy.

Copyright © 2024 HealthDay. All rights reserved.

 

Study shows psychedelic drug psilocybin gives comparable long-term antidepressant effects to standard antidepressants, but may offer additional benefits

Psilocybin as good as SSRI for depression, but doesn’t lower sex drive, gives better sense of well-being and psychosocial functioning

European College of Neuropsychopharmacology

A direct comparison between the experimental psychedelic drug psilocybin and a standard SSRI antidepressant shows similar improvement of depressive symptoms, but that psilocybin offers additional longer-term benefits.

The comparison, between psilocybin (the active ingredient in “magic mushrooms”) and the SSRI escitalopram gave similar long-term improvements in depressive symptoms over a 6-month period, however patients taking psilocybin also reported better psychosocial functioning including experiencing a greater sense of meaning in life and psychological connectedness.

The work is presented for the first time at the ECNP Congress in Milan. A related paper will appear in the peer-reviewed journal Lancet eClinicalMedicine1 to coincide with the conference presentation (see details below). Lead researcher Mr Tommaso Barba (PhD candidate from Imperial College, London) said:

“This is the first work to compare the long-term effects of these two drugs in the context of overall well-being, not just freedom from depression.  In previous work we had found that both treatments led to comparable improvements in alleviating symptoms of depression at the 6-week mark, such as sadness and negative emotions.  However, this work shows that psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work and social functioning. These results appeared to be maintained over a 6-month follow-up period. In addition, in previous work* we had found that psilocybin also improves sexual drive, in contrast to SSRIs which tend to lower libido in many patients. So overall it seems psilocybin might give additional positive mental health benefits.”  

SSRI drugs (selective serotonin reuptake inhibitors), such as Prozac, Paxil and Zoloft, are one of the main types of drugs used to treat depression. However, around a third of patients don’t respond to SSRI treatment, so for them psilocybin may offer an alternative, although this was not studied in this trial.

Tommaso Barba continued:

“SSRIs work well, but not for everyone. They are also associated with some side effects. However this work implies that psilocybin generally seems to offer a real alternative, and perhaps additional benefits, to people who are worried about taking conventional antidepressants”.

The researchers, from Imperial College in London, undertook a 6-month study (phase 2, double-blind, randomised controlled trial) with 59 patients with moderate to severe depression. 30 were treated with a single dose of psilocybin, 29 patients were given a six-week course of escitalopram. Each group received similar psychological support of around 20 hours in total. Both groups showed significant improvement in depressive symptoms, even up to 6 months after treatment (the researchers stopped monitoring at 6 months). However those given psilocybin reported greater improvements in social functioning and psychological connectedness, with large effect sizes.

Co-first author Dr David Erritzoe, Clinical Director and Deputy Head of the Centre for Psychedelic Research, Imperial College, London, commented:

“This is important because improving connectedness and having greater meaning in life can significantly enhance a person's quality of life and long-term mental health. The study suggests that psilocybin therapy might be a more holistic treatment option for depression, addressing both the symptoms of depression and overall well-being. This could make a substantial difference in the overall happiness and daily activities of those suffering from depression, providing a more joined-up approach to mental health treatment”.

The researchers note that the patients were only treated for 6 weeks, and that many of the patients received additional treatments over the 6-month follow up.

Dr Erritzoe cautioned:

“Psilocybin is still an experimental drug; it has not yet been approved for general use. It is administered in highly controlled and protected environments: these precautions are not found in recreational psychedelic use, which is known for having unpredictable and potentially harmful effects, especially for vulnerable people struggling with mental health issues”. 

Commenting, Johan Lundberg (Adjunct Professor of Psychiatry at the

Department of Clinical Neuroscience, Karolinska Institute, Stockholm) said:

“This report is an important attempt to compare the clinical value of psilocybin compared to a state-of-the-art treatment of major depressive disorder. The results come with several caveats, including the lack of a non-inferiority analysis and failure to report other interventions given during the follow-up period. That said, as a hypothesis generating piece it may benefit the field substantially.  For now, we don’t know if psilocybin will be approved for the treatment of major depression, but if so, it won’t be for everyone. Some future patients might prefer psychedelic treatment over SSRI, but some patients may be intimidated by the dramatic alterations in perception and confrontations with challenging emotions that psychedelic drugs promote”.

This is an independent comment, Professor Lundberg was not involved in this work.

Notes:

1. Publication details: Effect of psilocybin versus escitalopram on depression symptom severity in patients with moderate-to-severe major depressive disorder: observational 6-month follow-up of a phase 2, double-blind, randomised, controlled trial. In press at Lancet eClinicalMedicine. Authors: David Erritzoe, Tommaso Barba, Kyle T. Greenway, Roberta Murphy, Jonny Martell, Bruna Giribaldi, Christopher Timmermann, Ashleigh Murphy-Beiner, Michelle Baker Jones, David Nutt, Brandon Weiss, and Robin Carhart-Harris. Paper reference 10.1016/j.eclinm.2024.102799
2. See Psychedelic experiences linked with improved sexual function | Imperial News | Imperial College London

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Method of Research

Randomized controlled/clinical trial

Mount Sinai expands Psychedelic Research Center with new facility in upper Manhattan

The Mount Sinai Hospital / Mount Sinai School of Medicine

 

image: 

From left to right:

Dr. Amy Lehrner, Dr. Rachel Yehuda, Renee Parsons, Bob Parsons, Dr. Eric Nestler, Dr. Rene Kahn. 

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Credit: Mount Sinai Health System

Mount Sinai Health System this week celebrated the opening of an expansion of its psychedelic psychotherapy research center into a new location and announced a foundational $5 million gift from The Bob & Renee Parsons Foundation. The center has been renamed The Parsons Research Center for Psychedelic Healing.

The new location is designed to support the Center's capacity to facilitate a growing number of rigorous clinical trials that focus on well-known compounds like MDMA, psilocybin, ketamine, and potentially others in the future. These chemical compounds have garnered significant attention in academic medicine for their potential to alleviate symptoms of post-traumatic stress disorder (PTSD), depression, anxiety, and other stress-related conditions.

The Foundation’s gift, which comes at a pivotal time for the field, will expand the Center's capacity for therapy, research, and therapist training, including a primary focus on veterans.

Located at 600 West 112th Street, on the southwest corner of Broadway, the new space will house six treatment rooms and a group therapy room, with features to enable therapy supervision, teaching, and research. Large floor-to-ceiling windows provide natural light and a view of the surrounding tree-lined streets.

“Since its initial launch in 2021, our psychedelic psychotherapy research center has made progress towards our understanding of the therapeutic potential for psychedelic-assisted psychotherapy,” said Rachel Yehuda, PhD, Director of The Parsons Research Center for Psychedelic Healing. “The recent decision by the Food and Drug Administration to withhold approval for MDMA-assisted therapy has cast some uncertainty as to how and when psychedelic therapy will be broadly available, but has also made clear that there is a critical need to advance rigorous psychedelic research. Our team remains steadfast in our commitment to this work and to ensure the incredible momentum that has been generated by academic researchers does not falter.”  

Dr. Yehuda went on to say, “This is an existential moment for the field of psychedelic research in mental health, and rather than backing away from investment, as some are doing, The Bob & Renee Parsons Foundation is shining a light on what has become a darker path forward. Thanks to their vision and commitment and the continued generosity of our donors, we will meet the needs of the moment.” 

“My own battle with PTSD lasted for decades after I returned from the Vietnam War.  It was psychedelic-assisted therapy that finally brought me home after all those years,” said Bob Parsons, United States Marine Corps Vietnam war veteran and co-founder of The Bob & Renee Parsons Foundation. “Despite the FDA’s recent decision on MDMA, we’re digging in and funding more research because I have all the evidence I need—I know it works.”

The expansion of the Center reflects Mount Sinai’s commitment to providing institutional resources, strong scientific vision, and the established track record necessary to push forward with groundbreaking clinical trials. The gift from The Bob & Renee Parsons Foundation reflects an understanding by the Foundation that the moment demands serious and careful research and a deep commitment to uncovering effective treatments for veterans, who disproportionately experience conditions like PTSD that have been resistant to conventional therapies.

“The space was designed to embrace the importance of setting in therapeutic outcomes. From the moment our patients enter the beautifully designed Center, they will feel that they are in a place of safety and healing, which is paramount to maximizing the impact of the therapy sessions,” said Amy Lehrner, PhD, Clinical Director of The Parsons Research Center for Psychedelic Healing. “The views of nature, natural light, and complementary design will communicate serenity and warmth, setting a new standard for applying this nascent science. While solutions for traumatized people have been few and far between until now, with the advances we have made through this new space and the highly trained practitioners within, we now see renewed hope and healing.”

The Center is currently developing protocols for several studies, including pivotal group therapy studies, which required the creation of a large group space. The Center's expanded capacity allows for multiple simultaneous dosing sessions and group integration sessions, essential for advancing this critical work.

Mount Sinai investigators affiliated with the Center will also be conducting research on ketamine-assisted psychotherapy and psilocybin for patients with major depression and for the treatment of intergenerational trauma, as well as MDMA-assisted therapy for patients with eating disorders. Almost all trials will examine the mechanism of action of psychedelics using the latest developments in neuroimaging, molecular neuroscience, and natural language processing. These initiatives underscore the Center's role as a leader in developing innovative and effective treatments for mental health conditions. The Center also plans to continue to expand its focus on training and education of mental health clinicians in the use of psychedelic-assisted therapies.  The Center has provided training and education free of charge to 250 clinicians thanks to a prior $5 million gift from The Bob & Renee Parsons Foundation in 2021.

“We are hopeful that the cutting-edge research and training being done at Mount Sinai will go on to transform the lives of veterans, and others, suffering from debilitating mental health conditions,” said Renee Parsons, co-founder of The Bob & Renee Parsons Foundation. “Bob and I know firsthand the detrimental impacts of PTSD—not only on the individual but their entire family. We remain committed to battling the stigma surrounding mental health and shining a light on promising treatments like psychedelic-assisted therapy.”

“New treatment options are desperately needed for the millions of people, both civilians and veterans, who suffer from mood and anxiety disorders like PTSD and major depression,” said Dennis S. Charney, the Anne and Joel Ehrenkranz Dean of Icahn Mount Sinai and President for Academic Affairs for the Mount Sinai Health System. “Mount Sinai researchers lead on the frontier of biomedicine, applying scientific rigor while also challenging clinical and scientific dogma to emerge as true innovators. Under Dr. Yehuda’s leadership and through the unwavering support of The Bob & Renee Parsons Foundation, this new space enables us to propel our efforts with the speed, safety, and quality that will have a meaningful impact on the field of psychedelic psychotherapy and the patients we serve.”

About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time—discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 9,000 primary and specialty care physicians and 11 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals, Best in State Hospitals, World Best Hospitals and Best Specialty Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report® “Best Hospitals” Honor Roll for 2024-2025. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

About The Bob & Renee Parsons Foundation
The Bob & Renee Parsons Foundation offers support to nonprofit organizations successfully working to empower, educate, nurture and nourish people during what is often the darkest time of their lives. Founded in 2012 by philanthropists and business leaders Bob and Renee Parsons to provide hope and life-changing assistance to the country’s most vulnerable populations, The Bob & Renee Parsons Foundation offers critical funding at critical times to those in need. The Foundation’s giving is driven by the core belief that all people – regardless of race, religion, roots, economic status, sexual orientation or gender identity – deserve access to quality healthcare, education and a safe place to call home. Follow @WeDealInHope on social media or visit TBRPF.org, to learn more about partner organizations and the important work being done in the community.

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Entrance to The Parsons Research Center for Psychedelic Healing at Mount Sinai

Psychedelic-assisted psychotherapy treatment room within The Parsons Researh Center for Psychedelic Healing at Mount Sinai 

Waiting Area within The Parsons Research Center for Psychedelic Healing at Mount Sinai

Interior of The Parsons Research Center for Psychedlic Healing at Mount Sinai

Credit

Mount Sinai Health System