Speaker: Prescription psilocybin for depression, anxiety may be available in 3 to 5 years

Stephen Ross, MD, associate director of NYU Langone Center for Psychedelic Medicine, provided an overview of data on psilocybin for treating depression and anxiety at the American Psychiatric Association’s annual meeting.

“Psilocybin is a rapidly acting anxiolytic and antidepressant, with a single dose that worked for at least seven weeks, and that by itself was a new thing in psychiatry,” Ross said during a presentation, regarding a 2016 trial conducted at NYU. “We knew about ketamine working rapidly for depression and working for 1 to 2 weeks, but something that could work quickly as an anxiolytic and antidepressant and last up to 2 months was the strongest part. When we followed people out to the end, we found that 26 weeks later, there were enduring antidepressant and anxiolytic effects.”

Ross and colleagues conducted the double-blind, placebo-controlled, crossover trial at the NYU Dental College, recruiting from the NYU Clinical Cancer Center. They randomly assigned a total of 29 patients with cancer-related anxiety and depression to receive either single dose psilocybin for 0.3 mg/kg or niacin, which was the active control, both in conjunction with psychotherapy. Anxiety and depression evaluated between groups before the crossover at 7 weeks served as the primary outcomes.

Results showed immediate, significant and sustained improvements in anxiety and depression before the crossover, as well as decreases in cancer-related demoralization and hopelessness, an improvement in spiritual well-being and an increase in quality of life. Psilocybin was linked to lasting anxiolytic and antidepressant effects among many participants at the 6.5-month follow-up, as well as lasting improvements in existential distress, quality of life and attitudes towards death.

Ross also highlighted a 2020 long-term, within-subjects follow-up analysis of self-reported symptomatology for 15 participants who completed the prior trial, with participants providing data at an average of 3.2 and 4.5 years after psilocybin administration.

Ross and colleagues noted sustained reductions in anxiety, depression, hopelessness, demoralization and death anxiety at the first and second follow-ups, with large within-group effect sizes. At the 4.5-year follow-up, between 60% and 80% of participants met criteria for clinically significant antidepressant or anxiolytic responses, and between 71% and 100% reported psilocybin-assisted therapy had positively changed their life, and they rated it among their most personally meaningful and spiritually significant life experiences.

Ross noted that the practice of psychiatry may come to look different if and when psilocybin becomes available as a prescription medicine.

“It is important to design a trial having some kind causal model and to build in neuroimaging biomarkers or certain scales to interrogate these mechanisms of action to understand the why,” Ross said. “At NYU Langone, we are looking to initiate a phase three research program in this area and we're making good progress with that. If this all works out, my prediction is that within maybe three to five years, psilocybin is going to be available and prescribed as a prescription medication, it will be limited by the Risk Evaluation and Mitigation Strategies program at FDA and there will probably be a big regulatory framework.”

Agin-Liebes, et al. J Psychopharmacol. 2020;doi:10.1177/0269881119897615.

Ross S, et al. J Psychopharmacol. 2016;doi:10.1177/0269881116675512.

Ross S. The role of psychedelics in psychiatry. Presented at: American Psychiatric Association Annual Meeting; May 1-3, 2021 (virtual meeting).