Psilocybin for Depression
(PSI-TNT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how adding different types of support affects psilocybin therapy for people with depression that hasn't improved with other treatments. Psilocybin, found in "magic mushrooms," has been studied for its potential to reduce depression symptoms when paired with safety monitoring or psychedelic-assisted therapy. The trial seeks individuals diagnosed with treatment-resistant depression, meaning they haven't responded to at least two different antidepressants. Participants should be willing to stop their current antidepressant medications and have a caregiver to assist them after treatment sessions.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking certain medications like antidepressants, antipsychotics, mood stabilizers, and others for at least 2 weeks before starting the trial and throughout its duration, if your doctor confirms it's safe.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin, the main ingredient in "magic mushrooms," is usually safe for treating depression. One study found that a single 25 mg dose, combined with psychological support, was well-tolerated by people with major depressive disorder. Over five years of follow-up, no serious side effects were reported. Participants in these studies experienced improvements in empathy, self-acceptance, and relationships.
Another review of different trials found that psilocybin often leads to significant reductions in depression symptoms. The evidence suggests psilocybin could be a promising option for people whose depression hasn't improved with other treatments. Overall, while more research is ongoing, current data indicates that psilocybin is generally safe for use in controlled settings.12345Why are researchers excited about this trial's treatments?
Unlike standard antidepressants, which typically involve selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), psilocybin offers a unique approach by acting on the brain's serotonin receptors in a different way. This compound, found in certain mushrooms, is being explored for its potential to rapidly alleviate depressive symptoms, possibly within hours to a few days, instead of the weeks often required by conventional medications. Researchers are particularly excited about psilocybin combined with psychedelic-assisted therapy (PAT), as this approach could enhance the therapeutic effects by integrating psychological support, potentially leading to more profound and lasting improvements in mood and mental health.
What evidence suggests that psilocybin might be an effective treatment for depression?
Research has shown that psilocybin, the active ingredient in "magic mushrooms," may help treat depression. In several studies, patients who took psilocybin experienced significant improvements in their depression symptoms compared to those who did not. One study found that a single 25 mg dose of psilocybin led to a greater reduction in depression symptoms over three weeks compared to a smaller dose. Another study demonstrated that the benefits of psilocybin therapy can last up to six months for people whose depression hasn't improved with other treatments.
In this trial, participants will receive psilocybin in one of two treatment arms: Psilocybin + Safety Monitoring (PSM) or Psilocybin + Psychedelic Assisted Therapy (PAT). These findings suggest that psilocybin, especially when combined with psychological support, could be a strong option for those struggling with depression.36789Who Is on the Research Team?
Ishrat Husain, MD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for adults with treatment-resistant depression, which means standard treatments haven't worked for them. Specific eligibility criteria are not provided, but typically participants must be in good general health and provide informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive psilocybin therapy with either safety monitoring or psychedelic assisted therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
University Health Network, Toronto
Collaborator