Study Finds Psilocybin Improves MDD in Patients With Cancer

An open-label study of psilocybin therapy for depression in patients with cancer found that 50% of participants achieved remission of depression symptoms within 1 week of receiving COMP360 psilocybin therapy.

The study, conducted by Maryland Oncology Hematology at the Aquilino Cancer Center in Rockville, included 30 patients who had been diagnosed with major depressive disorder (MDD) and cancer at various stages. All participants were actively receiving cancer treatment, half of them had been treated with antidepressants for their current depressive episode, and 19 had no prior experience with psychedelic substances. Patients received a 25 mg dose of COMPASS Pathways’ COMP360, followed by psychological support from specially trained therapists. Remission of depressive symptoms was reported following only 1 dose of the drug, with patients generally tolerating COMP360 psilocybin therapy well with no serious adverse events related to treatment. Remission was sustained for the study’s 8-week follow-up period.¹

“It’s an exciting study for the team at Aquilino Cancer Center, my colleagues at COMPASS, and the mental health care and oncology communities. It is pioneering a new approach to the mental health problems of people living with cancer. It suggests that simultaneous administration of COMP360 psilocybin therapy appears to be well tolerated and feasible,” Guy Goodwin, FMedSCI, DPhil, FRCPsych, chief medical officer of COMPASS Pathways, told Psychiatric Times^TM. Goodwin is also emeritus professor of psychiatry at the University of Oxford and a former WA Handley Chair of Psychiatry and head of the university’s Department of Psychiatry.

Psilocybin therapy, as administered in this study, usually involves 3 stages: preparatory, medication administration, and integration. During the preparatory stage, therapists help the patient understand their symptoms and prepare for the psychological or emotional effect of the medication. During the administration session, therapists observe the patient and maintain patient safety for 6-8 hours. In the integration stage, therapists discuss any psychedelic experiences from the medication and help the patient interpret these experiences.² In the COMPASS Pathways open-label study, “between 2 to 4 patients were given a 25mg dose of COMP360 psilocybin therapy at the same time, in conjunction with 1-on-1 support from a specially-trained therapist, throughout their 6- to 8-hour experience,” Goodwin told Psychiatric Times^TM. “This makes it the first clinical trial to test the safety and feasibility of psilocybin therapy with simultaneous administration to several patients and 1-on-1 psychological support.”

Patients in this study received COMP360, a synthesized formulation of psilocybin, the active ingredient in some species of mushrooms known as “magic mushrooms.”³ The drug received Breakthrough Therapy Designation from the US Food and Drug Administration in February 2018.⁴ Importantly, as neither participants nor raters were blinded to the selection of treatment, the researchers acknowledged that the results might have been influenced by expectancy bias.¹

Improving treatment methods for MDD and other depressive disorders in patients with cancer is of interest because research shows that poorer prognosis is reported in patients with comorbid cancer and depressive disorders,⁵ and that these patients are at higher risk for both suicidal ideation and completed suicide.⁶ “For complete cancer care, we need to focus on whole-person healing and include the mental wellbeing of our patients. This is not widely addressed today, but it’s time to do something about it. These study results have shown that psilocybin therapy may be helpful with MDD in cancer, and we look forward to doing further analysis and following up with additional studies,” said Manish Agrawal, MD, principal investigator of the study, in a press release. Agrawal is co-director of clinical research at the Aquilino Cancer Center.

“More than 80% of cancer patients in the US are treated in community cancer centers, so conducting research in this setting offers a real-world environment to test treatments in a location where patients are already seeking and receiving care,” Goodwin told Psychiatric Times^TM. “We believe the results of this trial could contribute to transforming the way we help cancer patients cope with the psychological impact of their diagnosis. Improving the mental health of patients is the inspiration for everything we do.”

References

1. Open-label study of COMP360 psilocybin therapy for depression in cancer patients demonstrates feasibility of simultaneous psilocybin administration in small groups. News Release. COMPASS Pathways. October 20, 2021. Accessed October 20, 2021.https://ir.compasspathways.com/news-releases/news-release-details/open-label-study-comp360-psilocybin-therapy-depression-cancer

2. Jann MW. Psilocybin revisited: The science behind the drug and its surprising therapeutic potential. Psychiatric Times. 2021;38(3). Accessed October 21, 2021. https://www.psychiatrictimes.com/view/psilocybin-revisited-science-behind-drug-surprising-therapeutic-potential

3. About psilocybin therapy. COMPASS Pathways. Accessed October 21, 2021. https://compasspathways.com/our-research/psilocybin-therapy/about-psilocybin-therapy/

4. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. News Release. COMPASS Pathways. October 23, 2018. Accessed October 20, 2021.https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

5. Sherrill C, Smith M, Mascoe C, et al. Effect of treating depressive disorders on mortality of cancer patients. Cureus. 2017;9:e1740. Accessed October 21, 2021. https://www.cureus.com/articles/8003-effect-of-treating-depressive-disorders-on-mortality-of-cancer-patients

6. Myers CJ, Retamero C. Suicidal ideation and behaviors in oncology patients. Psychiatric Times. 2021;37(8). Accessed October 21, 2021. https://www.psychiatrictimes.com/view/suicidal-ideation-and-behaviors-oncology-patients