TOPLINE:
A single dose of psilocybin administered in a group setting with one-on-one psychological support was associated with a significant and lasting reduction in depression severity among adults with cancer and major depressive disorder, a small study shows.
METHODOLOGY:
Depression remains common in patients with cancer, and common treatment approaches — antidepressants and psychotherapy — have demonstrated limited success.Researchers explored the safety, feasibility, and efficacy of psilocybin-assisted group therapy in 30 patients with major depressive disorder and cancer — about half with earlier-stage disease and half with metastatic disease.In this single-center, open-label, phase 2 study, participants received one-on-one and group therapy sessions before, during, and after receiving a single 25-mg psilocybin dose.Alongside individual therapy sessions, each cohort of three to four participants received group sessions guided by a therapist who provided educational material and worked to foster trust among participants.
TAKEAWAY:
Participants experienced a significant reduction in depression severity, demonstrating a 19.1-point reduction in Montgomery-Asberg Depression Rating Scale scores from baseline to follow-up at week 8.Overall, 80% of patients showed a lasting response to psilocybin treatment and 50% showed full remission of depressive symptoms by week 1, which persisted for at least 8 weeks.The approach was effective for patients with curable and noncurable cancer — with almost 80% in the curable group and 62% in the noncurable group showing clinically meaningful declines in depressive symptoms. The researchers also noted improvements in patients’ anxiety, pain, demoralization, disability, and spiritual well-being.No suicidality or other serious treatment-related adverse events occurred; treatment-related nausea and headache were generally mild and expected.
IN PRACTICE:
“Beyond tolerability, psilocybin therapy led to clinically meaningful reductions in depressive symptoms,” the authors concluded. “To our knowledge, this is the first study to show the feasibility of a group-therapy approach for psilocybin‐assisted treatment in patients with cancer. This innovative framework offers increased scalability and dissemination of psilocybin treatment in real‐world settings.”
Among the 28 participants available for exit interviews, the authors reported that, overall, “participants described that the group/simultaneous model fostered a sense of connectedness, meaning, and transcendence through the shared psilocybin experience and group integration.”
SOURCE:
The study, led by Manish Agrawal, MD, Sunstone Therapies, Rockville, Maryland, was published online on December 21, 2023, in Cancer, along with an editorial and related article on patient acceptability of psilocybin-assisted group therapy.
LIMITATIONS:
The study lacked a control group, and the sample size was small and lacked diversity. The study was also not powered to statistically adjust efficacy measures on a possible group effect.
DISCLOSURES:
The study was funded in part by Compass Pathways. Some authors reported various relationships with Compass Pathways and Sunstone Therapies.
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