In a phase II study reported in a research letter in JAMA Oncology, Agrawal et al found that a single treatment with psilocybin (COMP360) with a 1:1 therapist-to-patient ratio reduced symptoms of depression in patients with cancer and major depression disorder treated at a single community cancer center.
Study Details
The study included 30 patients treated at Aquilino Cancer Center, Maryland Oncology Hematology, Rockville. Cohorts of three to four patients were simultaneously treated with a 25-mg dose of COMP360 in adjacent rooms open to a common space, in a 1:1 therapist-to-patient ratio. (COMP360 is a proprietary stabilized, high-purity polymorphic crystalline synthesized formulation of psilocybin.)
The cohorts received one session of group therapy and two integration sessions combined with individual therapy. Outcome measures included safety and improvement of depression; depression was primarily measured by the Montgomery-Asberg Depression Rating Scale (MADRS), with higher scores indicating more severe depression. Sustained response to treatment was defined as a decrease in MADRS score of ≥ 50% from baseline to weeks 3 and 8; remission was defined as a score of < 10 posttreatment.
Key Findings
All 30 patients completed the study. Patients had a mean age of 56 years, 70% were women, 47% had curable and 53% had noncurable cancers, and 50% had received prior antidepressant drug therapy.
No treatment-related serious adverse events occurred, and no suicidality was observed based on the Columbia Suicide Severity Rating Scale. Adverse events were mild or expected and included headache in 24 patients (80%), nausea in 12 (40%), altered mood in 8 (27%), anxiety in 7 (23%), and hallucinations in 1 (3%).
A reduction in MADRS scores from baseline to posttreatment of 19.1 points (95% confidence interval [CI] = −22.3 to −16.0 points, P < .001) by week 8 was observed. Sustained response occurred in 24 patients (80%), and full remission of symptoms was observed in 15 patients (50%).
The findings were supported by outcomes on self-reported measures of depressive symptoms. Quick Inventory of Depressive Symptomatology–Self-Report scores declined by an average of 5.9 points (95% CI = −7.2 to −4.6 points), representing a 48% reduction from baseline to week 8. The Maudsley Visual Analogue Scale showed a reduction of 46.2 points (95% CI = −61.6 to −30.7 points), representing a 53% decrease in self-rated depression severity.
The investigators stated, “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 one 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.”
Manish Agrawal, MD, of Sunstone Therapies, Rockville, MD, is the corresponding author for the JAMA Oncology article.
Disclosure: The study was supported by COMPASS Pathways, a mental health-care company, and by the Shady Grove Adventist Medical Center Foundation. For full disclosures of the study authors, visit jamanetwork.com.
