According to findings from a Phase II clinical trial, people with cancer and severe depression may benefit from psilocybin, a hallucinogenic substance present in some Psilocybe mushrooms. In addition to reporting a reduction in depressive symptoms, trial participants treated with psilocybin also expressed positive opinions about the therapy during the post-trial interview.
A particular subtype of serotonin receptor in the brain is bound by psilocybin, which changes mood, perception, and cognitive function. As of right now, the US Food and Drug Administration has not approved psilocybin for clinical use and has classified it as a Schedule I drug, which is characterized as having no recognized medical use and a high potential for abuse.
Psilocybin can alter mood, perception, and cognition by attaching to a particular subtype of serotonin receptor in the brain. Currently categorized as a Schedule I drug due to its high potential for abuse and lack of recognized medical use, psilocybin has not received FDA approval for clinical use.
At baseline, the enrolled participants’ depression scores ranged from moderate to severe. Following eight weeks of therapy, patients’ depression severity scores decreased by an average of 19.1 points, a significant enough decrease to suggest that most of them were no longer depressed, according to Dr. Agrawal and his associates.
Additionally, 50% of participants showed complete remission of depressive symptoms after one week, which persisted for eight weeks, and 80% of participants experienced a sustained response to treatment. Headache and nausea were common side effects of the treatment, but they were usually not severe.
“As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumor,” said Dr. Agrawal. “This was a small, open-label study and more research needs to be done, but the potential is significant and could have implications for helping millions of patients with cancer who are also struggling with the severe psychological impact of the disease.”
In a follow-up study, which was directed by Yvan Beaussant, MD, MSc, of the Dana-Farber Cancer Institute, Dr. Agrawal served as senior author and collected feedback from trial participants through exit interviews. The experiences that the participants shared were generally positive. Regarding safety, they reported that belonging to the group helped to allay their anxieties and heightened their sense of readiness for therapy sessions.
In terms of the effectiveness of the therapy, they believed that belonging to the group enhanced and deepened their experience, which in turn helped them to feel compassion for one another and self-transcendence. It was also discovered that the therapy was supported differently by the use of both individual and group sessions. For instance, the inclusion of both individual and group sessions contributed a sense of “togetherness” to the therapy while preserving its intimate, introspective nature.
“As a hematologist and palliative care physician and researcher, it was profoundly moving and encouraging to witness the magnitude of participants’ improvement and the depth of their healing journey following their participation in the trial. Participants overwhelmingly expressed positive sentiments about their experience of psilocybin-assisted therapy while emphasizing the importance of the supportive, structured setting in which it took place,” said Dr. Beaussant.
“Many described an ongoing transformative impact on their lives and well-being more than two months after having received psilocybin, feeling better equipped to cope with cancer and, for some, end of life.”
Before this intervention is used in clinical settings, more research with a greater patient sample size and a control group to compare its results with placebo or other treatments is necessary.