Research

Study demonstrates psilocybin feasibility for depression in cancer patients

The study is an exploratory trial testing the safety and feasibility of simultaneous administration of COMP360 psilocybin.

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New data from the Aquilino Cancer Center Study has shown the safety and feasibility of psilocybin therapy for the treatment of depression in cancer patients.

The Maryland Oncology Hematology (MOH) at the Aquilino Cancer Center has announced promising data from its open-label clinical study of psilocybin therapy to treat depression in cancer patients. 

The study is an exploratory trial testing the safety and feasibility of simultaneous administration of COMP360 psilocybin to 30 cancer patients living with major depressive disorder, combined with one-on-one psychological support. The simultaneous group administration of psilocybin in a cancer centre was pioneered by the team at the Aquilino Cancer Center which allowed the research team to test the value of group support for cancer patients, as well as the potential for increased scalability in providing psilocybin therapy in real world settings.

The study found that 50 per cent of participants achieved remission in depression symptoms after a single administration of psilocybin therapy.

Medical oncologist and clinical director at the Aquilino Cancer Center, and the trial’s principal investigator, Manish Agrawal, MD, commented: “Research on cancer traditionally focuses on treatments for the physical impacts of the cancer, ignoring the devastating impact that cancer has on a patient’s mental wellbeing. These new promising findings for psilocybin are a huge milestone towards improving the quality of life for cancer patients who suffer from depression.

“While it’s premature to draw any definitive conclusions from this feasibility study, simultaneous administration of psilocybin therapy appears to be well-tolerated and promising in treating major depressive disorder for cancer – bringing us one step closer to transforming cancer care.”

As part of the study, patients were followed for eight weeks to measure the changes in depression symptoms. The patients were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-administered, symptom questionnaire scoring the severity of depression from 0 (depressive symptoms absent) to 60 (severe depression). 

The 30 patients in the study began with an average MADRS score of 25.9, representing moderate depression, and the data demonstrated that after psilocybin therapy the score dropped by an average of 19.1 points. 

A sustained response rate was seen by 24 patients, and 15 patients showed remission of depression symptoms one week after a single dose of psilocybin, which was sustained up to eight weeks.

“Cancer can ravage a patient’s entire life. In addition to attacking the body, cancer also impacts a patient’s mental and emotional wellbeing. It’s time we practice whole-person healing in oncology, which means meeting all the needs of our patients, both physical and psychological,” said Paul Thambi, MD, an investigator on the trial and a medical oncologist with Maryland Oncology Hematology. 

“With these new findings on psilocybin, we are helping to expand the treatment options for the psychological impact of cancer that many patients face.”

The study was sponsored by COMPASS Pathways, a mental health care company and developer of the COMP360 psilocybin therapy. It is noted that given this was an open-label study in which neither patients nor raters were blinded, there is a significant risk that the results incorporate a large expectancy bias.

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