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Usona's Phase 3 psilocybin trial for depression, with Bellevue and Vancouver sites, has no results yet

Usona Institute's uAspire trial, a Phase 3 test of psilocybin for major depressive disorder, enrolled 238 people at 29 sites, including Bellevue and Vancouver, Washington, and its primary data collection ended January 5, 2026. As of November 2, 2026, neither the trial registry nor Usona's website showed results.

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Where uAspire stands

The ClinicalTrials.gov record for uAspire (NCT06308653), last updated October 21, 2026, lists the Phase 3 trial as active, not recruiting, with 238 participants enrolled (actual) at 29 sites.1 Its primary completion date, the registry's term for when data for the main outcome were last collected, is January 5, 2026, marked actual. Overall study completion is estimated for January 30, 2027, and no results are posted on the record.1

Usona's psilocybin page says the institute "has completed enrollment of its Phase 3 study."2 Its news list, checked November 2, showed no uAspire results or filing plan; the newest items were an August 19, 2026 paper on well-being as a trial endpoint and a March 2026 chemistry paper.3

What the trial measures

uAspire is a randomized, double-blind, multicenter trial of psilocybin in adults with major depressive disorder. Its sponsor is the Usona Institute, a medical research organization in Fitchburg, Wisconsin.14 The primary outcome is the change in depression scores on the Montgomery-Asberg Depression Rating Scale (MADRS), scored by central raters, from baseline to Day 43, compared with placebo.1

That is the same main measure Usona used in its Phase 2 trial, published in the September 5, 2023 issue of JAMA. In that study, 104 adults at 11 U.S. sites were randomized to psilocybin or a niacin placebo, each given with psychological support. By day 43, MADRS scores were 12.3 points lower with psilocybin than with niacin. There were no serious treatment-emergent adverse events, but overall and severe adverse events were more frequent with psilocybin.4 Usona says the FDA granted its psilocybin program Breakthrough Therapy designation for major depressive disorder in 2019.5

uAspire is the larger, later-stage test of that result. As of November 2, Usona hadn't said when it will report it or whether it plans to file for approval.23

The Washington sites

Two of uAspire's 29 sites are in Washington: Seattle Neuropsychiatric Treatment Center in Bellevue and the VA Portland Health Care System's site in Vancouver.1 People who took part at those sites are in a Phase 3 psilocybin trial that finished collecting its main data nearly ten months ago and whose results haven't been released. Seattle Neuropsychiatric Treatment Center and the Vancouver VA site are also listed for Ascend, Definium's Phase 3 trial of an LSD-based drug for depression, where the clinic's listed city is Seattle (see our post on Definium's trials).6

Usona's psilocybin has been used in Seattle research before. The University of Washington's completed trial of psilocybin for frontline clinicians with depression lists its study drug as "Psilocybin (Usona Institute)."7 Psilocybin itself remains a Schedule I substance under Washington law.8 The Seattle research entry covers the region's trial sites and research groups, Seattle by the numbers gathers the figures, and the timeline dates the law and research milestones around them.

What happens next

  • January 30, 2027: estimated study completion, per the registry.1
  • Results: no date announced by Usona as of November 2, 2026.23
  • Where to watch: results, when posted, appear on the NCT06308653 record and on Usona's news list.13

Sources

  1. NCT06308653, A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (uAspire). ClinicalTrials.gov, record updated October 21, 2026.
  2. Psilocybin (drug development page). Usona Institute, checked November 2, 2026.
  3. Usona Institute home page, The Latest News and Research. Usona Institute, checked November 2, 2026.
  4. Raison CL, et al. Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. JAMA, September 5, 2023. PMID 37651119.
  5. FDA grants Breakthrough Therapy designation to Usona Institute's psilocybin program for major depressive disorder. Usona Institute, November 22, 2019.
  6. NCT07592689, A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend). ClinicalTrials.gov, record updated October 23, 2026.
  7. NCT05163496, Frontline Clinician Psilocybin Study. ClinicalTrials.gov, record updated March 18, 2025.
  8. RCW 69.50.204, Schedule I. Washington State Legislature.

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