It’s been a good year for medicinal psilocybin. In October 2018, the Food and Drug Administration (FDA) approved the hallucinogenic compound psilocybin as a “breakthrough therapy” for treatment-resistant depression. Now, the FDA has doubled down and approved it as a breakthrough therapy for major depressive disorder as part of a major 80-person clinical study. If psilocybin proves to be an effective therapeutic tool in these trials, it could expedite its journey from the laboratory to the clinic.
Major depressive disorder (MDD), which affects about 16 million adults in the U.S., is the leading cause of disability for people aged 15 to 44, according to the Anxiety and Depression Association of America. It is perhaps best characterized by an overwhelming feeling of sadness, but it can also have other symptoms ranging from loss of appetite to suicidal ideation.
Many different treatment options exist for MDD such as talk therapy and a wide range of medications like selective serotonin reuptake inhibitors (SSRIs), among which are Zoloft and Prozac. While these types of medications are effective for many people, about 10 to 30 percent suffering from major depression are resistant to their effects.
As the FDA realized last year, psilocybin could potentially be an important form of relief for those with treatment-resistant major depression. Their extension of the breakthrough therapy status to psilocybin for major depression in general is a welcome development for those who can’t find relief with conventional treatment or are looking for other options.
The new psilocybin trial is being conducted by the non-profit Usona Institute at seven different sites around the U.S. and expects to enroll up to 80 patients. The first trial site opened in October at New York University and other sites will soon open in Baltimore, Maryland; San Francisco, California; Madison, Wisconsin; Chicago, Illinois; Miami, Florida; and New Haven, Connecticut. The trials will be double-blinded and placebo-controlled, meaning that patients will be administered either a single dose of psilocybin or a placebo of vitamin B3, but neither doctor nor patient will know which was administered in advance.
The Usona trial is now in its Phase II stage after successfully completing a limited study with a small group of patients who demonstrated that the substance was safe. When Phase II wraps up in 2021, the researchers will be eligible to expand the study to even more people as part of a Phase III trial that will assess whether psilocybin is more effective than available treatments. If all goes well during the third trial, Usona can ask the FDA to approve psilocybin for clinical use in patients with major depressive disorder.
There’s no guarantee that the research will show that psilocybin is effective in treating major depression—only about one in three FDA-approved breakthrough therapies ever make it to market. However, decades of research in the area suggests there’s good reason to believe that psilocybin has a lot to offer those suffering from mood disorders.
Researchers at Johns Hopkins University, for instance, have studied the effects of psilocybin in terminally ill patients and found that it was quite effective in treating depression. Indeed, many of the researchers involved in those trials recently wrote an article calling for moving psilocybin from a Schedule I drug—which means it has no therapeutic benefits in the eyes of Johnny Law—to a Schedule IV drug, which would make it much easier to study as a medicine. As the researchers note, psilocybin carries a low risk of abuse, but has a lot of potential as a therapeutic tool.
Between the two new breakthrough therapy designations for psilocybin and the ongoing Phase III clinical trial on MDMA underway at MAPS, it looks like the government is finally starting to warm up to the idea that psychedelics can be medicines. Cultures around the world have known this for millennia, but hey, it’s better late than never.