Psilocybin for Depression
(uAspire Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug psilocybin for depression?
Several clinical trials have shown that psilocybin can reduce symptoms of depression, with some patients experiencing significant, long-term improvements even after just one or a few sessions. It has been suggested as a rapid-acting treatment for depression, with studies indicating marked decreases in symptom severity.12345
Is psilocybin generally safe for humans?
Psilocybin has been studied for its safety in humans, and research suggests that it can be used safely under controlled conditions. In a study with healthy adults, escalating doses of psilocybin were administered without serious adverse effects, and another study indicated that certain mushroom extracts did not worsen heart conditions in a lab setting. However, caution is advised, especially for individuals with cardiovascular issues.25678
How is the drug psilocybin different from other depression treatments?
Psilocybin is unique because it is a naturally occurring compound found in certain mushrooms and works by affecting serotonin receptors in the brain, which can lead to rapid improvements in depression symptoms after just one or two doses, unlike traditional antidepressants that often require daily use and take weeks to show effects.124910
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or placebo under the 'Set and Setting' Protocol
Follow-up
Participants are monitored for changes in depressive symptoms, functional disability, and safety measures
Open-label Re-administration (optional)
Eligible participants may receive additional doses of Psilocybin 25 mg under the 'Set and Setting' Protocol
Treatment Details
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Usona Institute
Lead Sponsor
Worldwide Clinical Trials
Collaborator