Millions could benefit from psilocybin therapy, shows study

Key Points
  • A recent study conducted by Emory University, the University of Wisconsin-Madison, and UC Berkeley found that up to 62% of patients receiving treatment for depression in the US could qualify for psilocybin therapy if approved by the FDA.
  • The study evaluated 9 million Americans currently receiving depression treatment against eligibility criteria from recent psilocybin trials, with estimates ranging from 24% to 62% of patients being eligible.
  • The researchers noted that the 62% upper-bound estimate could be conservative, as it only considered current patients and did not account for potential new patients seeking psychedelic therapy.
  • The findings emphasize the need for regulatory bodies, policymakers, insurers, and the healthcare community to prepare for potential FDA approval of psilocybin therapy and ensure its optimal benefit for patients.

With 14.8 million people in the US living with Major Depressive Disorder, 2.7 million of these patients meet the criteria for Treatment Resistant Depression. Equally, with limited to no innovation in mental health treatment for decades, this number highlights a desperate need for new therapies. Psychedelics have shown incredible promise in emerging research as such treatments.

While the FDA recently delivered a huge blow to both patients and industry with the rejection of MDMA-assisted psychotherapy for the treatment of PTSD, the organisation is set to consider the approval of psilocybin for the treatment of depression later this year.

This latest study, carried out by Emory University, the University of Wisconsin-Madison, and UC Berkeley, determined that up to 62% of patients currently receiving treatment for depression could qualify for psilocybin therapy if approved.

“Our findings suggest that if the FDA gives the green light, psilocybin-assisted therapy has the potential to help millions of Americans who suffer from depression” said Syed Fayzan Rab, an Emory MD candidate and the study’s lead author, in a press statement.

“This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale.”

The researchers evaluated the population of 9 million Americans receiving treatment for depression against various eligibility criteria used in recent clinical trials of psilocybin for depression.

The team then came up with estimates to see who would be eligible for psilocybin-assisted psychotherapy.

The first “lower-bound” range estimated that 24% of patients would be eligible if the strict criteria of initial trials were applied.

The “mid-range” estimated that 56% would be eligible based on criteria likely to be used in real-world medical settings, and an “upper-bound” range estimated that 62% would be eligible after accounting for patients with multiple exclusionary conditions.

However, the researchers emphasised that the 62% upper-bound estimate is likely a conservative one, as the analysis focused only on currently treated individuals and did not account for the potential influx of new patients drawn by the appeal of psychedelic medicine.

Equally, they emphasise that these projections depend on FDA approval parameters and real-world implementation factors such as insurance coverage decisions and the availability of trained practitioners.

“While our analysis is a crucial first step, we’ve only scratched the surface in understanding the true public health impact psilocybin therapy may have,” said Dr. Charles Raison, in a press statement. Dr. Raison is a collaborator on the study and the lead investigator on one of the largest clinical trials looking at the efficacy of psilocybin therapy for depression.

“Ultimately, the realisable potential of this treatment rests in the hands of regulatory bodies, policymakers, insurers, and the healthcare community at large.

“It’s our hope that these findings spur productive discussions and proactive preparations to optimize the benefit to patients while minimising unintended consequences.”

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