A new study published in the New England Journal of Medicine tested the use of psilocybin for depression treatment. Unfortunately for the psychedelic community, the results weren’t overwhelmingly different for psilocybin. The goal of the study was to compare the effects of psilocybin with a six-week course of escitalopram, which is a selective serotonin reuptake inhibitor (SSRI), for MDD. The Journal wrote that this trial did not show a significant difference in antidepressant effects between psilocybin and escitalopram in a selected group of patients. On a positive note, secondary outcomes generally favored psilocybin over escitalopram, but the report said that the analyses of these outcomes lacked correction for multiple comparisons.
The study was funded by the Alexander Mosley Charitable Trust and Imperial College London’s Centre for Psychedelic Research; ClinicalTrials.gov number, NCT03429075. opens in new tab. It did suggest that larger and longer trials are required to compare psilocybin with established antidepressants.
“In a field of research where it is very difficult to separate treatments in head-to-head comparative efficacy trials, this study found signals favoring psilocybin therapy over escitalopram. This is an encouraging investigator-initiated study that supports the need for additional clinical investigations in larger, well-powered studies to more accurately determine the efficacy of COMP360 psilocybin in MDD”, said George Goldsmith, CEO, and Co-founder of COMPASS Pathways (NASDAQ: CMPS). “At COMPASS, we are already committed to a full clinical development program of psilocybin therapy in treatment-resistant depression, and we know there is much more work to be done so that we can bring evidence-based innovation to patients who have run out of options in a number of mental health illnesses.”
A total of 59 patients were enrolled; 30 were assigned to the psilocybin group and 29 to the escitalopram group. Patients were assigned in a 1:1 ratio to receive two separate doses of 25 mg of psilocybin 3 weeks apart plus 6 weeks of daily placebo (psilocybin group) or two separate doses of 1 mg of psilocybin 3 weeks apart plus 6 weeks of daily oral escitalopram (escitalopram group); all the patients received psychological support. The primary outcome was the change from baseline in the score on the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16; scores range from 0 to 27, with higher scores indicating greater depression) at week 6. There were 16 secondary outcomes, including QIDS-SR-16 response (defined as a reduction in score of >50%) and QIDS-SR-16 remission (defined as a score of ≤5) at week 6.