Psilocybin for Depression
Trial Summary
What is the purpose of this trial?
This trial explores the safety of a single 25mg dose of psilocybin given to adults with depression that hasn't improved with other treatments and who have ongoing suicidal thoughts. Psilocybin works by changing brain cell communication to improve mood and reduce negative thoughts. Psilocybin has shown promise in treating depression, anxiety, and other mental health conditions in recent studies.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since it involves psilocybin, it's best to discuss with the trial team or your doctor.
What data supports the effectiveness of the drug psilocybin for treating depression?
Is psilocybin safe for human use?
Psilocybin has been studied for its safety in humans, showing that it can be used safely under controlled conditions, although caution is advised with higher doses. Some studies have shown that it does not worsen certain heart conditions and may protect against cell injury, but it can cause side effects like vomiting and hallucinations.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 acts quickly to reduce depression symptoms, often with just one or two doses, unlike traditional antidepressants that require daily use and can take weeks to show effects. It works by affecting serotonin receptors in the brain, which is different from most standard antidepressants.124910
Research Team
Scott Aaronson, MD
Principal Investigator
Sheppard Pratt Health System
Eligibility Criteria
This trial is for adults aged 18-65 with Major Depressive Disorder who haven't improved after trying at least two medications and have ongoing suicidal thoughts but no immediate intent to harm themselves. It's not open to those with schizophrenia, bipolar disorder, borderline personality disorder, or current substance abuse issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 25mg psilocybin under supportive conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
Sheppard Pratt Health System
Lead Sponsor
COMPASS Pathways
Industry Sponsor