Study Reveals Potential Demand for Psilocybin-Assisted Therapy for Depression in the United States

The evidence is piling up, Efficacy The U.S. Food and Drug Administration (FDA) is considering approving psilocybin, the active ingredient in “magic mushrooms,” as a treatment for depression in the near future. As this critical moment approaches, a key question arises: just how many people could potentially benefit from this promising but unproven treatment?

The first peer-reviewed study to shed light on this critical investigation was led by researchers at Emory University, the University of Wisconsin-Madison, and the University of California, Berkeley. Hallucinogens A US research paper published on 24 September 2024 (ISSN: 2997-2671, Genomic Press, New York) has calculated an initial estimate of the potential demand for psilocybin-assisted therapy for depression in the US. By analysing national survey data on depression prevalence and treatment, together with eligibility criteria for recent landmark clinical trials, the researchers determined that 56% to 62% of patients currently being treated for depression, or a staggering 5.1 to 5.6 million people, could be eligible for psilocybin therapy if approved.

“Our findings suggest that, if approved by the FDA, psilocybin-assisted therapy could help millions of Americans suffering from depression. This highlights the importance of understanding the practical realities of deploying this new treatment at scale.”

Syed Faizan Rab, a medical school candidate at Emory University and lead author of the study,

To arrive at their estimates, the researchers first determined that of the roughly 15 million U.S. adults with depression, roughly 9 million would receive treatment in a given year. They then assessed this population against various eligibility criteria used in recent clinical trials of psilocybin for depression. Their analysis yielded a range of estimates: a “lower limit” of 24% when applying the strict criteria from the first trials, a “mid-range” of 56% based on criteria more likely to be used in real-world clinical practice, and an “upper limit” of 62% when accounting for patients with multiple exclusions.

Notably, roughly one-third of the jump from the low end to the midpoint comes from the inclusion of patients with alcohol and drug use disorders, for whom there is growing evidence that psilocybin may be beneficial rather than contraindicated. However, even the high end estimate of 62% is likely conservative, as this analysis only included individuals currently in treatment and did not take into account the potential influx of new patients attracted by the allure of psychedelics.

The researchers caution that these projections depend heavily on the FDA's exact approval parameters and subsequent real-world implementation factors. Insurance coverage decisions, availability of trained practitioners, and regional differences in access could all significantly limit the ultimate adoption of psilocybin therapy. Moreover, if approval includes off-label uses for conditions other than depression, demand could surge even further in unpredictable ways.

“While our analysis is an important first step, we are only scratching the surface regarding the true public health impact of psilocybin therapy,” said study collaborator Charles Layson, PhD, principal investigator of one of the largest clinical trials examining the efficacy of psilocybin therapy for depression. “Ultimately, the viability of this treatment rests on regulators, policymakers, insurers, and the medical community at large. We hope that these findings will encourage productive discussion and proactive preparation to maximize benefits to patients and minimize unintended consequences.”

As the psychedelic renaissance continues to gather momentum, this study provides an important glimpse into the possibilities and challenges that lie ahead. With millions of lives potentially at risk, it highlights the urgent need for further research to refine demand estimates and inform equitable and effective provision if psilocybin therapy is approved.