Usona Institute will begin its Phase 3 Clinical Trial investigating psilocybin for Major Depressive Disorder (MDD), the company announced today.

According to a release, the uAspire trial will start with an initial six-week randomized double-blind treatment period. Participants will be monitored for one year to characterize the treatment durability and long-term safety of psilocybin treatment.

“The initiation of the Phase 3 uAspire trial marks an important milestone in the clinical development of psilocybin as a potential new treatment for major depressive disorder,” Usona Institute Chief Medical Officer Dr. Mike Davis said in a statement. “Following the robust safety and efficacy findings from our Phase 2 study PSIL201, the uAspire trial is designed to deepen our understanding of psilocybin’s treatment durability and long-term safety.”

The Institute earned FDA designation back in 2019.