Psychedelic therapy could benefit millions of depressed Americans, study finds

NEW YORK, Sept. 13 (UPI) -- More than 5 million Americans in treatment for depression could benefit from therapy with psilocybin -- the active ingredient in "magic mushrooms," a new study finds.

The study, published online Thursday in Psychedelics, involved researchers from Emory University School of Medicine in Atlanta, the University of Wisconsin-Madison and University of California-Berkeley.

Prior studies upheld the benefits of psilocybin for treatment-resistant depression, and the Food and Drug Administration at some point will be asked to approve this psychedelic -- a type of drug that temporarily alters thinking, mood and sense of time. It's also known as a hallucinogen because it can radically change visual and auditory perceptions.

When integrated with talk therapy, experts say psilocybin may help individuals cope with depression, substance abuse, obsessive-compulsive disorder and other conditions.

However, in August, the FDA rejected another psychedelic drug -- MDMA, also known as ecstasy -- as a treatment for post-traumatic stress disorder, citing faulty data, problematic research conduct and major risks, such as the possibility of heart problems, injury and abuse.

Researchers suspect psilocybin could be next in line for the FDA's review as a mental health therapeutic agent, specifically for treatment-resistant depression.

The agency has designated psilocybin as breakthrough therapy for patients diagnosed with major depressive disorder or treatment-resistant depression. It is now considering the approval of psilocybin for medical use.

"I was really interested in the public health and economic demand of these new modalities," the study's lead author, Fayzan Rab, a fourth-year medical student at Emory, told UPI in explaining why he chose to quantify the number of people with treatment-resistant depression who could be eligible for psilocybin.

Anywhere from 56% to 62% of people who have a depression diagnosis could be eligible for psilocybin therapy," based on the researchers' analysis of national survey data on depression prevalence and treatment, Rab said.

That percentage amounts to somewhere between 5.1 million and 5.6 million people, the researchers projected.

To come up with that estimate, researchers first established that about 9 million of the almost 15 million American adults with depression receive treatment in a given year.

Next, they conducted an evaluation of this population against various eligibility criteria employed in recent clinical trials of psilocybin for depression.

Their analysis produced a range of estimates: a "lower-bound" of 24% of patients eligible if they applied strict criteria of initial trials, a "mid-range" of 56% based on likely criteria in real-world medical situations, and an "upper-bound" of 62% after they used less stringent exclusion criteria.

It was significant that a third of the lower-bound to mid-range jump stemmed from the inclusion of patients with alcohol and substance use disorders, as mounting evidence indicates that psilocybin may be useful rather than contraindicated for them, researchers said.

Yet, it is likely that even the 62% upper-bound estimate is conservative, they noted, because the analysis centered only on people in current treatment and did not factor in the possible introduction of new patients enticed by the allure of psychedelic medicine.

"By establishing lower, middle and upper-bound estimates, the study offers a practical framework for healthcare policymakers, insurance companies and clinicians to plan for the potential introduction of psilocybin-assisted therapy," Elliot Marseille, director of the Collaborative for the Economics of Psychedelics at the University of California-Berkeley, told UPI.

In offering estimates of eligible individuals, "the paper underscores the importance of understanding the public health impact of such therapies and the potential challenges and opportunities in providing them to a broad patient population," said Marseille, the senior author of the study.

These projections hinge on the FDA's exact approval specifications and the implementation that follows in real life, researchers cautioned. Other factors that could ultimately limit the use of psilocybin-assisted therapy are insurance coverage decisions, availability of trained practitioners and regional variations in access.

However, the researchers pointed out that if clinicians prescribe psilocybin "off-label" for conditions other than depression, demand could swell in unforeseen ways.

Psilocybin-assisted therapy is "a very different model of healthcare delivery than we're used to," said Dr. Boris Heifets, an associate professor of anesthesiology at Stanford School of Medicine in Palo Alto , Calif.

While patients typically visit a mental healthcare practitioner's office to receive a prescription for a drug they will take daily, this type of therapy involves an hours-long orientation followed by a drug session, which can last up to eight hours, said Heifets, a neuroscientist who studies how psychedelics work.

Patients take this drug in a monitored setting, and then return for follow-up therapy sessions or engage in another form of psychological support, such as via a mobile app that performs an after-dosing assessment, he said.

Dr. Rakesh Jain, a clinical professor in the department of psychiatry at Texas Tech University School of Medicine-Permian Basin in Odessa Texas, called the study "very thought-provoking."

"We used to think psychedelics might just be a niche utilized drug in psychiatry," said Jain, whose research focuses on mood disorders.

"But this is study is demonstrating to us the truth -- that psychedelics could play a role in the lives of many millions of patients, and that's a big deal. It's perhaps a way broader spectrum of utilization than even I had anticipated prior to reading this article."