Results from a Phase II clinical trial suggest that psilocybin, a hallucinogenic compound found in certain mushrooms of the Psilocybe genus, may offer benefits to individuals dealing with cancer and major depression. The trial showed that participants treated with psilocybin not only reported a reduction in depressive symptoms but also spoke positively about the therapy in post-trial interviews.
The study’s findings have been published in two articles available online in Cancer.
Psilocybin, by binding to a specific serotonin receptor subtype in the brain, induces changes in mood, cognition, and perception. Despite its Schedule I classification—currently considered to have no accepted medical use and a high potential for abuse—multiple randomized controlled trials have demonstrated the safety and potential efficacy of psilocybin-assisted therapy. This approach combines psilocybin with psychological support from trained therapists and has shown promise in treating major depressive disorder. Ongoing research is also exploring the potential use of psilocybin-assisted therapy for conditions such as anxiety, addiction, and post-traumatic stress disorder.
In the recent Phase II open-label trial involving adults with cancer and major depression, conducted at Sunstone Therapies in Rockville, Maryland, 30 participants received a single 25 mg dose of synthesized psilocybin along with a 1:1 session with a therapist and group therapy support.
Lead author Manish Agrawal, MD, of Sunstone Therapies, highlighted the distinctive group approach of the study. Cohorts of three to four patients were simultaneously treated with 25 mg of psilocybin in adjacent rooms, with a 1:1 therapist-to-patient ratio. The cohorts underwent preparation for therapy and integration sessions as a group following the psilocybin session.
Participants initially had moderate to severe depression scores. After eight weeks of treatment, the study observed an average drop of 19.1 points in patients’ depression severity scores, indicating that the majority no longer experienced depression.
Moreover, 80% of participants sustained a positive response to treatment, and 50% achieved full remission of depressive symptoms after one week, maintained for eight weeks. Treatment-related side effects, such as nausea and headache, were generally mild.
Dr. Agrawal, reflecting on his experience as an oncologist, expressed optimism about the potential impact on cancer patients struggling with the psychological aspects of the disease. He emphasized that while this was a small, open-label study and further research is needed, the potential implications for assisting millions of cancer patients dealing with severe psychological impacts are significant.
Dr. Agrawal is also the senior author of a second study led by Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute. This study gathered feedback from trial participants during exit interviews, revealing generally positive experiences. Patients noted that being part of a group eased their fears and enhanced their preparedness for therapy.
In terms of therapeutic efficacy, participants felt that the group connection deepened their experience, contributing to self-transcendence and compassion. Both individual and group sessions were found to support the therapy in different ways, combining an intimate introspective process with a sense of togetherness.
Dr. Beaussant, a hematologist and palliative care physician and researcher, expressed the profound impact witnessed during participants’ improvement and healing journey. The overwhelmingly positive sentiments expressed by participants about psilocybin-assisted therapy, coupled with the importance of the supportive, structured setting, were notable.
Despite these promising results, before this intervention can be incorporated into clinical practice, additional studies with larger patient populations and a control arm for comparison are necessary to evaluate its effects against other treatments or placebos.
Source: Wiley