240 Participants Needed

Psilocybin for Depression

(uAspire Trial)

Recruiting at 23 trial locations
KW
RK
JW
RT
DF
DW
SM
Overseen BySaundra Maass-Robinson, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Trial Phase: Phase 3
Sponsor: Usona Institute
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study
I have been diagnosed with major depression and have been feeling depressed for at least 60 days.
I can swallow pills.
See 1 more

Exclusion Criteria

Are hepatitis or HIV positive
Meet DSM-5-TR criteria for active post-traumatic stress disorder within 6 months prior to Screening
I have severe liver or kidney problems.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or placebo under the 'Set and Setting' Protocol

6 weeks
1 visit (in-person) for dosing, multiple visits for preparation and integration

Follow-up

Participants are monitored for changes in depressive symptoms, functional disability, and safety measures

1 year
Regular in-clinic visits and bi-weekly telephone visits

Open-label Re-administration (optional)

Eligible participants may receive additional doses of Psilocybin 25 mg under the 'Set and Setting' Protocol

During the 1-year Follow-up Period

Treatment Details

Interventions

  • Psilocybin
Trial Overview 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.
Participant Groups
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.

Psilocybin is already approved in United States, European Union for the following indications:

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Approved in United States as Psilocybin for:
  • Treatment-resistant depression (TRD) under Breakthrough Therapy designation
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Psilocybin for:
  • Treatment-resistant depression (TRD) under PRIME designation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Usona Institute

Lead Sponsor

Trials
18
Recruited
1,100+

Worldwide Clinical Trials

Collaborator

Trials
70
Recruited
15,800+

Findings from Research

Psilocybin has shown promise in clinical trials for reducing symptoms of depression, indicating its potential as a novel treatment option.
Patients with treatment-resistant depression (TRD) may benefit the most from psilocybin therapy, although the risks associated with its use are still not fully understood.
Assessing potential of psilocybin for depressive disorders.Kozak, Z., Johnson, MW., Aaronson, ST.[2023]
Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.
Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.
The pharmacology of psilocybin.Passie, T., Seifert, J., Schneider, U., et al.[2016]
Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

References

Assessing potential of psilocybin for depressive disorders. [2023]
The pharmacology of psilocybin. [2016]
[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
[Hallucinogenic mushrooms]. [2018]
Intravenous mushroom poisoning. [2019]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
A Proposal to Study the Safety and Efficacy of Psilocybe cubensis in Preclinical and Clinical Studies as a Therapeutic Alternative for Major Depressive Disorder. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Structure-Activity Relationships for Psilocybin, Baeocystin, Aeruginascin, and Related Analogues to Produce Pharmacological Effects in Mice. [2023]