It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
Sunday, September 22, 2024
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:
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
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, visithttps://www.mountsinai.org or find Mount Sinai onFacebook,Twitter andYouTube.
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
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