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Psychedelic Therapy

Psilocybin for Depression (uAspire Trial)

Phase 3
Recruiting
Research Sponsored by Usona Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from trial baseline to trial day 43
Awards & highlights
Pivotal Trial

Summary

This trial is testing psilocybin, a substance from mushrooms, to see if it can help adults with depression who may not respond well to current treatments. Psilocybin works by affecting brain chemicals related to mood. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as a breakthrough therapy by the FDA in 2019.

Who is the study for?
Adults diagnosed with Major Depressive Disorder as per DSM-5-TR criteria can join this trial. Participants must be at least 18 years old and willing to take a single dose of Psilocybin or placebo.
What is being tested?
The study tests the effectiveness of a single oral dose of Psilocybin (25 mg or 5 mg) compared to an inactive placebo in treating depression symptoms, with follow-up for one year to assess lasting effects.
What are the potential side effects?
Possible side effects may include changes in sense perception, mood alteration, nausea, headache, dizziness, and psychological distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from trial baseline to trial day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and from trial baseline to trial day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43
Secondary study objectives
Change in central rater Clinical Global Impression-Severity (CGI-S) total score from Baseline to Trial Day 43
Change in on-site rater administered Sheehan Disability Scale (SDS) score from Baseline to post-dose Day 43

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Psilocybin 25 mgExperimental Treatment1 Intervention
During the Double-blind Period, participants randomized to receive Psilocybin 25 mg will receive a single dose administered orally as a capsule and taken with water, along with the "Set and Setting" (SaS) Protocol. The "Set and Setting" (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.
Group II: Long-Term Follow-UpExperimental Treatment2 Interventions
After the initial 6-week Double-blind Period, all participants will proceed to a 1-year Follow-up Period. Participants will be followed via in-clinic visits and telephone visits during which clinic staff will assess changes in MDD symptom severity and safety measures including concomitant medications, adverse events (AEs), and suicidal ideation and behavior. Participants will also engage in group psychosocial support sessions, including psychoeducation, throughout this period. Participants may also be eligible to receive open-label re-administration(s) of Psilocybin 25 mg under the "Set and Setting" (SaS) Protocol if re-administration eligibility criteria are met.
Group III: Psilocybin 5 mgActive Control1 Intervention
During the Double-blind Period, participants randomized to receive Psilocybin 5 mg will receive a single dose administered orally as a capsule and taken with water, along with the "Set and Setting" (SaS) Protocol. The "Set and Setting" (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.
Group IV: Inactive PlaceboPlacebo Group1 Intervention
During the Double-blind Period, participants randomized to receive inactive placebo will receive a single dose of Microcrystalline Cellulose (MCC) 25 mg administered orally as a capsule and taken with water, along with the "Set and Setting" (SaS) Protocol. The "Set and Setting" (SaS) Protocol includes preparatory meetings with two Facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two Facilitators, and 4 hours of post-dose integration sessions with Facilitators. During the dosing session, participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.

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Who is running the clinical trial?

Worldwide Clinical TrialsOTHER
63 Previous Clinical Trials
14,525 Total Patients Enrolled
Usona InstituteLead Sponsor
15 Previous Clinical Trials
737 Total Patients Enrolled
~100 spots leftby Apr 2025
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