20 Participants Needed

Psilocybin for Depression

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SR
KS
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Overseen ByKimberly Swartz, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sheppard Pratt Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 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?

Several clinical trials have shown that psilocybin can reduce symptoms of depression, and it has been well tolerated with limited side effects. Some patients with treatment-resistant depression have experienced significant, long-term improvements after just one or a few sessions.12345

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

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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

I am between 18 and 65 years old.
I have been diagnosed with Major Depressive Disorder.
Significant level of suicidal thoughts with active ideation and without immediate intent
See 1 more

Exclusion Criteria

Current alcohol or substance use disorder
I have a history of a serious mental health condition like schizophrenia or bipolar disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 25mg psilocybin under supportive conditions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Multiple visits from Baseline to Week 12

Treatment Details

Interventions

  • Psilocybin
Trial OverviewThe study tests the safety and effects of a single dose of Psilocybin (25mg) given in a supportive setting to see if it can help people with treatment-resistant depression and chronic thoughts of suicide.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin

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
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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?

Sheppard Pratt Health System

Lead Sponsor

Trials
23
Recruited
7,800+

COMPASS Pathways

Industry Sponsor

Trials
15
Recruited
1,400+

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]