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Psychedelic Therapy

Long-Term Follow-Up for Major Depressive Disorder (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

uAspire Trial Summary

This trial aims to assess the effects of Psilocybin on adults with Major Depressive Disorder. Participants will receive either Psilocybin 25 mg, Psilocybin 5 mg,

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.Check my eligibility

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.See study design

What are the potential side effects?

Possible side effects may include changes in sense perception, mood alteration, nausea, headache, dizziness, and psychological distress.

uAspire Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from trial baseline to trial day 43

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43

Secondary outcome measures

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

uAspire 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Worldwide Clinical TrialsOTHER

61 Previous Clinical Trials

14,147 Total Patients Enrolled

Usona InstituteLead Sponsor

12 Previous Clinical Trials

518 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized the use of Psilocybin at a dosage of 25 milligrams?

"Our research team at Power rates the safety level of Psilocybin 25 mg as a 3 on our scale. This ranking is due to this trial being in Phase 3, indicating existing efficacy data and thorough safety assessments."

Answered by AI

Are there currently any vacancies for participants in this ongoing trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular study is not ongoing. The trial was initially listed on 3/1/2024 and last revised on 3/6/2024. While this specific trial is not currently enrolling participants, there are a total of 1423 other studies that are actively seeking candidates."

Answered by AI

Who else is applying?

What site did they apply to?

Mountain View Clinical Research

Innovative Clinical Research, Inc.

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I can not find help I don’t know who I am and I have barely left my house in the past 3 years I’m terrified of everything and don’t what is real anymore.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Psilocybin for Major Depressive Disorder (MDD)

2024. "Psilocybin for Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06308653.

All > Mdd > Colorado Springs