The Food and Drug Administration (FDA) will allow a clinical trial to test the effectiveness of the hallucinogenic compound found in magic mushrooms – psilocybin – as a treatment for depression. Previous research has suggested that psilocybin can ease the symptoms of chronic depression in patients who have been resistant to other forms of treatment.
COMPASS Pathways has been given the approval by the FDA to proceed with an ongoing psilocybin therapy trial. The company was founded in 2016 with a goal of giving mental health patients faster access to evidence-based, innovative therapies.
George Goldsmith is the chairman and co-founder of COMPASS Pathways.
“We are excited to be starting this landmark trial which has the potential to transform lives,” said Goldsmith. “Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it.”
The next phase of the study by COMPASS will be focused on 216 patients in 12 to 15 research sites across Europe and North America, beginning in the UK later this month.
Psilocybin therapy combines a dose of psilocybin with psychological support. In previous academic studies across the United States and the UK, psilocybin therapy has proven to be effective and safe.
COMPASS co-founder Ekaterina Malievskaia is also the company’s chief medical officer. She explained: “The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North America working together with the goal of helping patients suffering with treatment-resistant depression.”
If the upcoming phase of the trial by COMPASS proves to be successful, the team will move into a third phase.