March 20, 2024
Usona Statement on Phase 3 Study of Psilocybin for Major Depressive Disorder (MDD) (uAspire)
Madison, WI USA. (March 20th, 2024) Usona Institute announces the launch of its Phase 3 clinical trial, titled "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)." Known as the uAspire trial, its launch represents the beginning of an important next stage in the development of psilocybin as a potential therapeutic option for those diagnosed with MDD.
"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," says Dr. Mike Davis, Chief Medical Officer at Usona Institute." 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. To ensure broad applicability of the study findings, we are committed to the inclusion of adults from diverse backgrounds and treatment settings, including top academic institutions, clinical research sites, and VA medical centers across the country.”
ClinicalTrials.gov Identifier: NCT06308653
Study Details: The uAspire trial is designed to evaluate the efficacy and safety of psilocybin 25 mg as a treatment for MDD that is administered, with psychosocial support, to adults when they experience a major depressive episode. Following an initial 6-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.
Further Information: For additional information or for inquiries about participation, please visit the study record at clinicaltrials.gov.
About Usona Institute: Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Their focus is the treatment of society’s most challenging mental health conditions for which existing treatments fall short. For more information visit www.usonainstitute.org .