Psilocybin‐assisted group therapy in patients with cancer diagnosed with a major depressive disorder
Cancer – December 18, 2023
Source: OpenAlex
Summary
Half of patients with cancer experiencing major depressive disorder achieved full remission of depressive symptoms after a single psilocybin dose, sustained for eight weeks. This breakthrough in Psychedelics and Drug Studies, relevant to Oncology and Psychiatry, involved 30 participants. Psilocybin, a compound from Chemical synthesis and alkaloids, showed a robust 19.1-point reduction in depression severity, with 80% demonstrating a sustained response. This safe approach signals a promising new Medicine for mental health in Internal medicine, potentially expanding beyond traditional Cannabis and Cannabinoid Research.
Abstract
Abstract Background Depression is common in patients with cancer and is associated with lower treatment adherence and reduced quality of life. Antidepressants and psychotherapy have limited success in improving depression among patients with cancer. This study explored the safety, feasibility, and efficacy of psilocybin‐assisted therapy in patients with cancer and major depressive disorder. Methods This phase 2, open‐label trial enrolled patients with curable and noncurable cancer and major depressive disorder at a single community oncology practice site. A single 25‐mg dose of psilocybin was administered simultaneously to cohorts of three to four participants with individual (4.25 hours in 1:1 therapist‐to‐patient ratio) and group therapeutic support (3.75 hours) before, during, and after psilocybin administration. Outcomes included depression severity, anxiety, pain, demoralization, and disability. Results Thirty participants completed the study. No psilocybin‐related serious adverse events occurred; treatment‐related adverse events (e.g., nausea, headache) were generally mild and expected. There were no laboratory or electrocardiogram abnormalities. No suicidality was reported. Efficacy was suggested with a robust reduction in depression severity scores from baseline to posttreatment of 19.1 points (95% CI, 22.3 to –16.0; p < .0001) by week 8. Eighty percent of participants demonstrated a sustained response to psilocybin treatment; 50% showed full remission of depressive symptoms at week 1, which was sustained for 8 weeks. Conclusions Psilocybin‐assisted therapy in group cohort administration was safe and feasible in patients with cancer and depression. Efficacy was suggested based on clinically meaningful reductions in depressive symptoms. The novel, group‐oriented format, compact delivery time, community cancer center setting, and one‐to‐one therapist‐to‐patient ratio could also add to therapeutic gains and efficiency of administration. Trial Registration NCT04593563. Plain Language Summary Depression is common in patients with cancer and associated with lower treatment adherence, reduced quality of life, and limited response to antidepressants and psychotherapy. We conducted a phase 2 trial to study a single dose of psilocybin administered in a group therapy setting with one‐to‐one therapist‐to‐participant psychological support to patients with curable and noncurable cancer and major depressive disorder. Findings of the study showed safety (no treatment‐related serious adverse events or suicidality) with psilocybin and suggested efficacy, with a significant reduction in depression severity scores from baseline to posttreatment. Further investigation is warranted.