A new paper published in the American Journal of Psychiatry examines the definition of “psychedelic-assisted psychotherapy” and offers a new way of thinking and describing the potential treatment.
COMPASS Pathways plc, a biotechnology company aimed at providing access to innovative and evidence-based mental health treatment, published the study authored by leading psychiatrists and researchers including COMPASS’s Chief Medical Officer, Dr. Guy Goodwin, and Co-founder and COMPASS board member, Dr. Ekaterina Malievskaia.
Psychedelic drugs have recently been studied more as an alternative and effective treatment for several mental health conditions, such as depression, obsessive-compulsive disorder and even alcohol use disorder. A study from researchers in Britain and published by the Cambridge University Press found psilocybin is not only effective in treating depression symptoms but may also be the most cost-effective treatment available.
“Psilocybin was shown to be cost-effective compared to the other therapies when the cost of therapist support was reduced by 50% and the psilocybin price was reduced from its initial value to £400 to £800 per person. From a societal perspective, psilocybin had improved cost-effectiveness compared to a healthcare perspective,” the study authors wrote.
Most studies refer to treatment using psilocybin or other psychedelics as “psychedelic-assisted psychotherapy” or “psychedelic-assisted therapy” and the authors of the COMPASS paper looked closer at the definitions and offered three primary conclusions: Psychological support is an essential element of psilocybin treatment but is not an independent psychotherapy as commonly understood, more research is needed to understand how to optimize psilocybin treatment and clarity on terminology is needed to better define psilocybin treatment.
In particular, the authors believe there needs to be clarification on how psilocybin treatment is characterized and suggest using the term “psilocybin treatment” when referring to psilocybin administration in addition to psychological support.
“The evidence we have seen from the most rigorous studies of psilocybin treatment to date, suggests that the efficacy of the treatment comes primarily from the drug itself, while psychological support is essential for safeguarding patients,” said Dr. Goodwin. “This clarity is important in the assessment of efficacy and safety of psilocybin, alongside standardized psychological support. Our ongoing phase 3 program of COMP360 psilocybin treatment for treatment-resistant depression aims to generate additional evidence in the context of this efficacy and safety assessment.”
COMPASS Pathways previously provided their own estimation as to when psilocybin-assisted therapies may obtain regulatory approval, believing that psilocybin therapy will achieve commercialization “by the beginning of 2027.” The company made the prediction at the Psych Global Symposium, held in London, England, described as “home to world-leading psychedelic research institutions and publicly traded companies, with direct access to London’s capital markets.”
The company is currently undergoing a phase 3 clinical trial for its proprietary psilocybin formula, COMP360, for treatment for treatment-resistant depression. The company completed its phase 2 study that revealed statistically significant and clinically meaningful improvement in depressive symptom severity after a single 25 mg dose of COMP360, alongside psychological support.
“The publication of our COMP360 psilocybin therapy study in the most prestigious peer-reviewed medical journal in the world is a proud moment for everyone involved,” said Dr. Goodwin. “We saw positive results in a particularly difficult to treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognised as a new treatment option in the future. We look forward to starting our phase 3 programme later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”
