With growing evidence supporting the effectiveness of psychedelic-assisted therapies, the U.S. Food and Drug Administration (FDA) is considering the approval of psilocybin—the active compound in "magic mushrooms"—as a treatment for depression.
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As this major decision looms, a pressing question arises: How many people could actually benefit from this new therapy?
A groundbreaking study, led by researchers from Emory University, the University of Wisconsin-Madison, and UC Berkeley, offers some insight. Published in the journal Psychedelics, the study estimates the potential demand for psilocybin-assisted therapy for depression in the U.S. The paper, titled "An Estimate of the Number of People with Clinical Depression Eligible for Psilocybin-Assisted Therapy in the United States," reveals that a significant portion of those currently receiving treatment for depression—between 5.1 and 5.6 million individuals—could be eligible for this therapy if the FDA gives it the go-ahead.
Syed Fayzan Rab, an MD candidate at Emory and the study’s lead author, explains the impact of these findings: “If the FDA approves psilocybin-assisted therapy, it could help millions of Americans dealing with depression.” However, he also points out that implementing such a treatment on a large scale will come with challenges that need to be addressed.
How the study made its estimates:
Researchers began by analyzing national survey data on depression and its treatment. Out of nearly 15 million American adults with depression, about 9 million receive treatment annually. The researchers then looked at how this group measured up against the eligibility criteria from recent clinical trials of psilocybin for depression.
Their analysis produced a range of estimates:
A "lower-bound" estimate of 24% if strict trial criteria were applied
A "mid-range" of 56% based on more likely real-world criteria
An "upper-bound" of 62% when factoring in patients with multiple conditions that could initially exclude them from treatment
Interestingly, including patients with alcohol or substance use disorders—groups that psilocybin may actually help—contributed to a significant portion of the mid-range estimate. Still, even the 62% upper-bound estimate may be conservative, as it only accounts for people already receiving treatment and doesn't consider the potential surge of new patients drawn to the therapy.
What could influence the demand:
While the numbers are promising, the study emphasizes that the true impact of psilocybin therapy will depend on a number of factors. FDA approval terms, insurance coverage, the availability of trained practitioners, and access to the therapy in different regions could all affect how many people ultimately benefit. If psilocybin is also approved for conditions beyond depression, demand could rise even further.
Dr. Charles Raison, a collaborator on the study and lead investigator in one of the largest psilocybin trials, cautions that these projections are just the beginning. “We’ve only scratched the surface in understanding the full public health impact of psilocybin therapy,” he says. The real potential of this treatment, he adds, will depend on how it’s handled by regulatory bodies, healthcare providers, and insurers. The goal is to maximize its benefit for patients while minimizing any unintended consequences.
What’s next:
As the interest in psychedelics for mental health continues to grow, this study offers a crucial glimpse into what lies ahead. Millions of lives could potentially be affected, making it urgent to continue research and prepare for how psilocybin therapy might be implemented if it’s approved.
This marks an exciting, yet complex, chapter in the evolving landscape of mental health treatment—one that will require thoughtful planning and collaboration across the healthcare system.
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