Assessment of psilocybin therapy for patients with cancer and major depression disorder

This innovative study is particularly interesting in several ways, including both using psilocybin-assisted therapy in a community cancer centre and using a potentially more efficient/cost-effective 1-to-1 (rather than the currently standard 2-to-1) therapist-to-patient ratio. The authors write: "About 15% of patients with cancer experience major depression, which is associated with lower treatment adherence and reduced quality of life. Yet, oncologists often feel inadequate to address mental health issues, and many treatments have limited success in treating depression.Psilocybin is a 5-HT2A receptor agonist with success in reducing a variety of psychiatric symptoms while using 2 therapists per patient. To create a scalable, rapidly effective depression treatment, this nonrandomized controlled trial administered psilocybin in a 1-to-1 therapist-to-patient ratio to groups of patients with cancer who were diagnosed with major depression disorder in a community cancer center.  Methods Thirty participants were recruited at Aquilino Cancer Center and through referrals from specialized psychiatric and oncology services. They were grouped into cohorts of 3 to 4 by timing of recruitment. Participants were adults with a diagnosis of cancer (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes C00-C97) and major depression disorder. The study protocol (Supplement 1) was approved by the Advarra Institutional Review Board, and written consent was obtained from each participant.  This was a phase 2, single-center, fixed-dose, open-label study. Cohorts of 3 to 4 patients were simultaneously treated with a 25-mg dose of COMP360 (COMPASS Pathways) in adjacent rooms open to a common space, in a 1-to-1 therapist-to-patient ratio. The cohorts received group therapy in 1 preparation and 2 integration sessions, supplemented by individual therapy. Outcome measures included safety and improvement in depression, which was primarily measured with the Montgomery-Asberg Depression Rating Scale (MADRS), with higher scores denoting greater severity. Sustained response to treatment was defined as a decrease in MADRS score of 50% or more from baseline to week 3 and week 8, and remission as a MADRS score lower than 10 posttreatment. Other measures of depression included the Quick Inventory of Depressive Symptomatology–Self-Report5 and the Maudsley Visual Analogue Scale.  Results A total of 30 participants were enrolled and completed the study per protocol; the attrition rate was 0%. The mean (SD) age was 56 (12) years with 9 (30%) men and 21 (70%) women (Table). Fourteen (47%) participants had curable cancers, while 16 (53%) had noncurable cancers. Half of the sample reported previous antidepressant drug therapy (n = 15).  No treatment-related serious adverse events occurred, and there was no suicidality based on the Columbia Suicide Severity Rating Scale. Adverse events were mild or expected and included headache (n = 24), nausea (n = 12), altered mood (n = 8), anxiety (n = 7), and hallucinations (n = 1).  Efficacy was suggested with a robust reduction in MADRS scores from baseline to posttreatment of 19.1 points (95% CI, −22.3 to −16.0 points; P < .001) by week 8. A sustained response was observed in 24 (80%) patients, with 15 (50%) patients showing full remission of depressive symptoms.  These findings were supported by self-reported measures of depressive symptoms. Quick Inventory of Depressive Symptomatology–Self-Report scores declined by an average of 5.9 (95% CI, −7.2 to −4.6) points, a 48% reduction from baseline to week 8. The Maudsley Visual Analogue Scale showed a change of −46.2 (95% CI, −61.6 to −30.7) points, a 53% decrease in self-rated depression severity.  Discussion To our knowledge, this is the first psilocybin therapy trial conducted in a community cancer setting rather than a psychiatric hospital or academic center. With an innovative study design of treating cohorts simultaneously, using 1 therapist per patient, and providing group therapy support, participants experienced clinically meaningful, rapid, and sustained improvement in symptoms of depression over 8 weeks following a single treatment of psilocybin therapy. This occurred in patients with both curable and metastatic cancer.  Limitations include a lack of control arm. Comparison with placebo and other antidepressant treatments for patients with cancer is needed. Nonetheless, this study demonstrates the safety and preliminary efficacy of psilocybin treatment for patients with cancer and depression using a scalable model with a 1-to-1 therapist-to-participant ratio and simultaneous administration, justifying a randomized clinical trial."

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