92 Participants Needed

Psilocybin-Assisted Psychotherapy for Depression

(PSI-1V2 Trial)

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Overseen ByZoe Doyle, RN
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like antidepressants, antipsychotics, mood stabilizers, and stimulants at least one month before starting the trial, if your doctor says it's safe.

Is psilocybin safe for use in humans?

Psilocybin has been studied in clinical trials and is generally considered safe when used under medical supervision, although it can cause temporary side effects like hallucinations and changes in perception. A study on healthy adults showed that escalating doses of psilocybin were well-tolerated, and research on depression and anxiety suggests it may be safe for these conditions as well.12345

How is psilocybin different from other depression drugs?

Psilocybin is unique because it is a natural compound found in 'magic mushrooms' and is used in a novel, rapid-acting therapy for depression, often requiring only one or two doses combined with psychotherapy, unlike traditional antidepressants that are taken daily and can have significant side effects.46789

Who Is on the Research Team?

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Joshua Rosenblat, MD, MSc

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals with treatment-resistant depression, meaning they haven't responded well to standard treatments. Participants must be adults who can safely receive psilocybin and are willing to undergo psychotherapy sessions.

Inclusion Criteria

Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation in addition to monthly check-ins by study staff to determine the first day of their last menstrual period
Current MDE must be moderate to severe, as determined by a MADRS score greater than 21
I will use condoms or other methods to prevent pregnancy during the study.
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Exclusion Criteria

Major neurocognitive disorder, as determined by clinical assessment, including administration of the Montreal Cognitive Assessment (MoCA)
Lifetime history of mania, hypomania or psychosis as determined by clinical psychiatric assessment and the MINI
Treatment with another investigational drug or other intervention within 30 days of Baseline (V2)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or two doses of psilocybin in conjunction with psilocybin-assisted psychotherapy

8 weeks
2-4 visits (in-person) for dosing sessions

Follow-up

Participants are monitored for safety, effectiveness, and various secondary outcomes such as quality of life and cognitive function

6 months
Regular follow-up visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin
Trial Overview The study is testing the effectiveness of one versus two doses of psilocybin in conjunction with psychotherapy on relieving symptoms of depression. It aims to determine which dosage level improves quality of life and cognitive functions more effectively.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Two Doses of PsilocybinActive Control1 Intervention
Group II: Single Dose of PsilocybinPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as Psilocybin for:
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Approved in European Union as Psilocybin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Centre for Addiction and Mental Health

Collaborator

Trials
388
Recruited
84,200+

Published Research Related to This Trial

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.
The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.
Intravenous mushroom poisoning.Curry, SC., Rose, MC.[2019]
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-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.
The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.
[Hallucinogenic mushrooms].Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

Citations

Intravenous mushroom poisoning. [2019]
The pharmacology of psilocybin. [2016]
[Hallucinogenic mushrooms]. [2018]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]
Assessing potential of psilocybin for depressive disorders. [2023]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
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]
Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]
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