Psilocybin for Major Depressive Disorder
Have you been diagnosed with major depressive disorder (MDD)? Explore alternative approaches to treatment for MDD.
About This Clinical Trial
What is the uASPIRE Study? The purpose of this clinical research study is to determine the safety and effectiveness of treatment with psilocybin in adults diagnosed with major depressive disorder (MDD). Currently available treatments for depression may not work for everyone, so alternative treatments are being sought through clinical research studies.
The uASPIRE Study is testing a single oral dose of an investigational drug for the treatment of MDD. We will look at the investigational drug to learn how well it relieves the symptoms of a major depressive episode compared to treatment versus a placebo group. Participants will also receive psychosocial support—sessions that address a person’s emotional, social, mental, and spiritual needs—throughout the study from trained study facilitators.
What is major depressive disorder? MDD is a mood disorder that causes a persistent feeling of sadness and loss of interest. It affects how you feel, think, and behave—and can lead to a variety of emotional and physical problems. It is often diagnosed when someone has a persistently low or depressed mood, feelings of guilt or worthlessness, lack of energy, sleep disturbances, and suicidal thoughts. For many people with MDD, symptoms are often severe enough to impact daily activities, such as work, school, relationships, and social activities.
What is the investigational drug? The investigational drug, psilocybin, is a naturally occurring psychedelic compound produced by more than 200 species of fungi. In previous studies, psychedelics like psilocybin have shown promise in their ability to alleviate symptoms of depression and provide an increased sense of well-being in some participants.
Are there any costs for study participation? If you are eligible and choose to participate in the study, you will receive the following at no cost:
- The investigational drug and other study treatments.
- Any study-required visits, tests, and assessments.
What is a clinical research study? A clinical research study is designed to test an investigational drug to determine if it works and is safe. This study will help researchers learn more about the safety and effectiveness of the investigational drug, potentially providing a new treatment option in the future for people with major depressive disorder.
Participation in this clinical research study is completely voluntary. Your decision to participate or not participate will have no effect on the medical care you receive now or in the future. If you are eligible to participate in the uASPIRE Study and choose to participate, you may stop participating at any time and for any reason.
Trial Status: Recruiting
Sponsor: Usona Institute
ClinicalTrials.gov: NCT06308653
What to Expect as a Trial Participant
- You will be randomly assigned to one of three groups:
- A dose of the investigational drug at 25 mg
- A lower dose of the investigational drug at 5 mg
- A placebo dose that does not contain any active investigational drug
- You’ll receive a single dose of the investigational drug (or placebo) at the start of the clinical trial. However, if your depression relapses during the Long-Term Follow-Up Period, you may be eligible for up to four additional doses of the investigational drug—at a dose of 25 mg—eegardless of your initial study treatment group.
- You’ll be in the study for up to 64 weeks. The study includes the following periods:
- Screening Period (Up to 5 Weeks)
- Preparation and Dosing Period (Up to 1 Week)
- Double-Blind Period (Up to 6 Weeks)
- Long-Term Follow-Up Period (Up to 52 Weeks)
Who Is Eligible For The Study?
You may be eligible if:
- You are at least 18 years old.
- You have been diagnosed with major depressive disorder (MDD)
- You have been experiencing a major depressive episode for at least 60 days.
- You are willing to stop taking medication for your condition until the end of the study and not start new types of therapy during the study.
There are other requirements to be eligible for this study. The study team will discuss them with you and give you an Informed Consent Form (ICF) to sign if you would like to participate in the uASPIRE Study.
Ready to Take the Next Step?
Contact Us to Learn More & See if You Qualify
Call for information on Psychedelic-Assisted Clinical Trials: 310-996-8966
Schedule a consultant and find out if participating in a clinical trial or other care option is right for you.
Crisis Support Disclaimer
Notice: If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or text the Crisis Text Line (text HELLO to 741741).