Vail Health’s pioneering study of psilocybin’s effects on depression kicks off next month
In preparation, OPTIMIZE leader Dr. Charles Raison held discussion with a woman whose experience with psilocybin helped her depression
Vail Health/Courtesy photo
In April, Vail Health’s Behavioral Health Innovation Center will kick off the second of two studies aimed at targeting depression. The OPTIMIZE study will examine the impacts of psilocybin, the active ingredient in psychedelic mushrooms, on people with major depressive disorder.
In preparation for the study, Vail Health held a discussion on the OPTIMIZE study and the impacts of psilocybin on one woman’s life on Monday, March 3, at Colorado Mountain College Vail Valley at Edwards.
Dr. Charles Raison, director of Vail Health’s Behavioral Health Innovation Center, led the discussion.
One woman’s recovery journey from depression, alcoholism, suicidal ideation
Meghan Bayersdorfer started having suicidal thoughts in seventh grade. Later, she found out she was genetically predisposed to depression. But “as long as I did well in school, I could kind of float by,” she said.
As she got older, she experienced life events that reinforced her depressive thoughts.
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“I felt like I was stuck and I kept getting more stuck,” Bayersdorfer said. “Alcohol shut the noise down for me.”
Bayersdorfer received inpatient treatment for the first time in 2016. At the time, she was a mother of two young boys and was studying for her master’s degree in early childhood education.
Nearly 10 years later, she had spent time in seven residential treatment experiences, tried “all” the SSRIs, Prozac, Wellbutrin and other antidepressants and antianxiety drugs. Bayersdorfer list of diagnoses included treatment-resistant depression, post-traumatic stress disorder, generalized anxiety and major depressive disorder. She was separated from her husband and kids and was living homeless.
“Nothing was working for me. I was desperate. So I started looking for something,” Bayersdorfer said. “Psychedelics became something I started researching.”
Bayersdorfer looked into ayahuasca and ketamine but ultimately decided to try a group psilocybin experience.
Bayersdorfer called her first experience with psychedelics “very dark and very scary. I felt like every inner demon that existed inside me came out, and they wanted to get me in the ring and take me down,” she said. “It was terrifying. It was scary. I cried a lot. And then I sat with it. And I think that was the key piece.”
The OPTIMIZE study has origins in the failure of antidepressants
The rate at which Americans die by suicide has been going up since the early 2000s. Most of the increase, Raison said, is made up of young people under 35.
The number of people being treated for depression has also been increasing. In 2001, about 14.5 million patients were being treated for depression. In 2015, it was 25 million. But the treatment system, for many people, is not working.
“If you take large groups of people that are really struggling with depression, about one in four will get an adequate response to an antidepressant,” Raison said. “There is a huge need to find something more, to find something different.”
The OPTIMIZE study focuses on psilocybin, the active ingredient in magic mushrooms.
“I think it’s incontrovertible that psychedelics are the largest breakthrough in my time as a clinician,” Raison said.
In 2023, Raison and his team published the results of a trial they conducted with 104 people diagnosed with depression. Half of the patients received one dose of a synthesized version of psilocybin, while the other half received a placebo. Then, the team measured how depressed the patients were over time. “This is totally different from how we typically do things,” Raison said.
Those who received the psilocybin saw their depression decrease more than twice as much as those who received the placebo. The results lasted for six weeks.
The human brain adjusts to antidepressants because they are taken every day, Raison said.
A single dose of psychedelics, as opposed to antidepressants “it’s in your body for say four, five, six hours, and then it’s gone, but people feel better for weeks or months afterwards, so what has happened is it has done something, it has lit something in people that then takes on a life of its own,” Raison said.
‘A tiny little spark of hope’ can be life-changing
Bayersdorfer said her first experience with psychedelics gave her “a tiny little spark of hope that maybe there was some reason why I had to be here.”
Every sequential experience, or ceremony, as she called them, “went a little bit deeper, and it made me feel like, ‘we are going to get out of this’ a little more,'” she said.
The ceremonies gave Bayersdorfer a different perspective on herself and her life.
In her last ceremony, she said, she came face to face with the same inner demons she saw during her first experience with psilocybin, but they seemed “tired.”
Bayersdorfer said psilocybin helped align her physical actions with her mental desires, like reducing her drinking, in a way willpower alone could not. “It’s life-changing,” she said.
“I don’t know what happened in my mind, but I can tell you that my husband sees it, my kids see it, my parents see it, and it’s incredible,” Bayersdorfer said.
The OPTIMIZE study examines how ‘macrodosing’ psilocybin can treat depression
The OPTIMIZE study will examine how to maximize the results of psilocybin in combating depression, both in impact and length.
All 140 study participants will receive a single dose of 25 milligrams of pure psilocybin, regardless of their body size. “It’s a strong, strong dose,” Raison said. This is known as a “macrodose.”
Each participant will take the psilocybin in a room in the Wiegers Mental Health Clinic outfitted like a living room. Two facilitators — one licensed therapist and one person with mental health experience and a bachelor’s degree — will stay with the participant for the entire experience. Participants will be offered an eye mask and music.
Ahead of taking the dose, participants will meet with their facilitators for three to four hours to discuss what will happen and what they hope to get out of the experience — a combination of psychoeducation and bonding, Raison said. The day after taking the psilocybin, participants will again meet with their facilitators, who will help them work through and learn from their experience. This processing session will be repeated twice more in the weeks following the experience.
Part of the study will include practicing vagus nerve stimulation, which may enhance memory formation and can be done noninvasively through the ear.
The study will also attempt to measure clinical change throughout people’s daily lives, before and after they receive a single dose of psilocybin.
To track this, participants will take an ecological momentary assessment four times per day that asks how they are feeling in the moment, beginning two weeks before and lasting two weeks after the dose.
Participants will also record thoughts on their day via a voice diary app called Fabla, which has been shown to yield more content than a written diary.
Participants will use another app, called an electronically activated recorder, before and after dosing. The app takes a randomized sampling of ambient sounds via digital audio several times per day (or hour). Raison said he has used the electronically activated recorder for more than 10 years.
“It gives you this view into how people spend their life,” enabling study leaders to see if people actually change the way they speak, act and treat others after taking psilocybin, Raison said.
The OPTIMIZE study will primarily involve patients from Eagle County and the surrounding areas. The study, which is closely regulated by the U.S. Food and Drug Administration and is free to participate in, is still accepting participants.
Medically healthy adults ages 18 to 70 are eligible if they meet the DSM-5 criteria for a major depressive episode or moderate or greater severity, with a duration of at least 60 days. English and Spanish speakers are eligible. People on antidepressants must be willing to come off them with the assistance of study staff.
Psychedelics carry risk, though this can be reduced by administering them in a safe, supportive, comfortable environment. “Even, sometimes, when they’re very hard, they can be helpful,” Raison said.
“Some other human does not need to go through what I went through to get to the other side,” Bayersdorfer said.
The OPTIMIZE Study is expected to begin enrolling participants in late April of this year. To sign up to receive an email when recruitment opens, visit VailHealthBH.org/Research-Notifications
