Results from a Phase II clinical trial indicate that psilocybin may benefit individuals with cancer and major depression.
In the study, trial participants treated with psilocybin not only experienced a lessening of depressive symptoms but also spoke highly of the therapy when interviewed at the end of the trial.
By binding to a specific subtype of serotonin receptor in the brain, psilocybin can cause alterations to mood, cognition, and perception. Psilocybin is currently classified as a Schedule I drug – defined as having no accepted medical use and a high potential for abuse – and is not approved by the US Food and Drug Administration for clinical use.
However, multiple randomised controlled trials have demonstrated the safety and potential efficacy of psilocybin-assisted therapy – which combines psilocybin with psychological support from trained therapists – to treat major depressive disorder.
Ongoing research is looking into the use of psilocybin-assisted therapy for various other mental health conditions, such as anxiety, addiction, and post-traumatic stress disorder.
Psychological impact of cancer
In this latest Phase II open-label trial, 30 participants received a single 25mg dose of synthesised psilocybin plus a 1:1 session with a therapist and group therapy support.
Participants enrolled had moderate to severe depression scores at baseline. After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 points. Furthermore, 80% of participants experienced a sustained response to treatment, and 50% showed full remission of depressive symptoms after one week, which was sustained for eight weeks.
“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 tumour,” said lead author Manish Agrawal, MD of Sunstone Therapies. “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.”
Dr Agrawal is also the senior author of a second study led by Yvan Beaussant, of Dana-Farber Cancer Institute, that gathered input from patients in the trial during exit interviews. In terms of safety, patients noted that being a part of the group calmed their fears and increased their sense of preparedness to engage in therapy. Regarding therapeutic efficacy, they felt that being connected to the group deepened and enriched their experience.
Dr Beaussant said: “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.”