Researchers have uncovered that psilocybin-assisted therapy may be safe and effective in patients with cancer and comorbid major depressive disorder, according to two novel studies published by Agrawal et al and Beaussant et al in Cancer.
Background
Psilocybin is a hallucinogenic chemical found in mushrooms of the genus Psiloybe. By binding to a specific serotonin receptor subtype in the brain, psilocybin may be capable of altering individuals’ mood, cognition, and perception.
The chemical is currently classified as a Schedule I drug—characterized as having no accepted medical use and a high potential for abuse—and has not been approved by the U.S. Food and Drug Administration for clinical use. However, previous randomized controlled trials have demonstrated the safety and potential efficacy of psilocybin-assisted therapy, a combination treatment that involves psilocybin and psychological support from trained therapists to treat major depressive disorder. Ongoing study are evaluating the use of psilocybin-assisted therapy for various other mental health conditions such as anxiety, addiction, and posttraumatic stress disorder.
Findings From the First Study
In the first study, a new phase II open-label clinical trial, the researchers assigned 30 patients with cancer major depressive disorder to receive a single 25-mg dose of synthesized psilocybin in addition to a session with a therapist and group therapy support. The patients presented with moderate to severe depression severity scores at baseline.
“This study was differentiated by its group approach. Cohorts of 3 to 4 patients were simultaneously treated with 25 mg of psilocybin in adjacent rooms open at the same time, in a [one-to-one] therapist-to-patient ratio. The cohorts had preparation for the therapy as well as integration sessions following the psilocybin session as a group,” explained lead study author Manish Agrawal, MD, of Sunstone Therapies.
After a follow-up of 8 weeks, the researchers observed that the patients’ depression severity scores decreased by an average of 19.1 points—a magnitude that would indicate the majority of the patients no longer experienced depression. Further, 80% of the patients experienced a sustained response to treatment, and 50% of them demonstrated full remission of depressive symptoms after 1 week of treatment. The researchers noted that treatment-related side effects such as nausea and headaches were generally mild.
Findings From the Second Study
In the second study, the researchers gathered input from the patients involved in the trial during exit interviews. The patients generally described having positive experiences and noted that being a part of the group therapy sessions reduced their fears and increased their sense of preparedness to engage in therapy. Further, the patients stated that being connected to the group deepened and enriched their experience—ultimately contributing to an overall feeling of self-transcendence and compassion for other members of the group.
The researchers also discovered that the use of both individual and group therapy sessions was found to support the treatment in different ways. For instance, the patients described the implementation of both sessions as allowing the therapy to remain an intimate, introspective process while adding a sense of “togetherness.”
Conclusions
“As an oncologist, I [have] experienced the frustration of not being able to provide cancer care that treats the whole [patient], not just the tumor,” stressed 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,” he highlighted.
“As a hematologist and palliative care physician, it was profoundly moving and encouraging to witness the magnitude of [patients'] improvement and the depth of their healing journey following their participation in the trial. [The patients] 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,” revealed lead study author of the second study Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute. “Many described an ongoing transformative impact on their lives and well-being more than 2 months after having received psilocybin, feeling better equipped to cope with cancer and, for some, end of life,” he underscored.
The researchers concluded that prior to the implementation of psilocybin-assisted therapy into clinical practice, further studies should include a larger number of patients and a control arm to better compare the safety and efficacy of the novel therapy.
Disclosure: For full disclosures of the study authors, visit acsjournals.onlinelibrary.wiley.com and acsjournals.onlinelibrary.wiley.com.
