Psilocybin-Assisted Psychotherapy for Depression

(PPP Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy that combines psilocybin, a substance found in certain mushrooms, with two different therapy styles to help people with treatment-resistant depression (TRD). Researchers aim to determine if aligning the therapy style with personal preference—either music-focused or mindfulness-focused—enhances treatment effectiveness. Participants will experience both therapy styles in separate sessions to compare outcomes. Ideal participants are adults who have not found relief from at least two traditional antidepressant treatments and are currently receiving psychiatric care. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications, especially those that interact with psilocybin, like trazodone or monoamine oxidase inhibitors. It's important to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that psilocybin-assisted therapy is generally safe and well-tolerated by participants. Research combining psilocybin with mindfulness-based stress reduction (MBSR) has found significant improvements in depression without serious side effects. Participants reported feeling better and experiencing fewer depressive symptoms after treatment.

In music-centered psilocybin therapy, studies also support its safety. A review of research highlighted how music can enhance the therapy experience. It helped participants explore their emotions more deeply, contributing to the therapy's safety and effectiveness.

Overall, psilocybin therapy for depression has shown promising results in terms of safety. It is well-tolerated, with research indicating it can significantly help people with mood disorders.12345

Why are researchers excited about this trial's treatments for depression?

Researchers are excited about psilocybin-assisted psychotherapy for depression because it offers a unique approach compared to traditional antidepressants like SSRIs and therapy. Unlike these standard treatments, psilocybin works by targeting serotonin receptors in the brain, potentially leading to rapid and profound changes in mood and perception. This compound, derived from certain types of mushrooms, may offer faster relief from depressive symptoms, with effects sometimes noticeable after just one or two sessions. Additionally, psilocybin's potential to facilitate deep psychological insights during therapy could provide long-lasting benefits, setting it apart from typical medications that often require daily use.

What evidence suggests that psilocybin-assisted psychotherapy could be effective for treatment-resistant depression?

Research shows that therapy using psilocybin, a compound found in certain mushrooms, can greatly improve depression symptoms. In this trial, participants will receive either mindfulness-centered psilocybin-assisted therapy or music-centered psilocybin-assisted therapy. Previous studies have shown that people who took psilocybin along with mindfulness exercises experienced more relief from depression than those using other methods. Another study found that music can enhance the positive effects of psilocybin on mood. These findings suggest that combining psilocybin with mindfulness or music can be effective. Additionally, psilocybin has eased major depression symptoms for at least a month after treatment. Overall, promising evidence indicates that psilocybin therapy can help people with depression that hasn't responded to other treatments.12345

Who Is on the Research Team?

KT

Kyle T Greenway, MD

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with treatment-resistant depression. Participants will receive two sessions of psilocybin-assisted psychotherapy, one with music-centered and one with mindfulness-centered approaches. They must be willing to be randomly assigned to either approach first and complete additional therapy sessions.

Inclusion Criteria

I can read and understand either French or English.
Able and willing to give informed consent to participate in the study and for the study clinicians to communicate with their psychiatrist throughout the intervention phase of the study
I am at least 21 years old.
See 7 more

Exclusion Criteria

My psychotherapy treatment won't be consistent during the study or started less than 3 weeks ago.
Prior use of serotonergic psychedelics in the past year and/or more than five life-time uses
I have had seizures, but not from childhood fever.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preference Assessment

Participants rate their preference for music-centered or mindfulness-centered psychotherapy approaches

4 weeks
1 visit (in-person)

Treatment Phase 1

Participants receive the first psilocybin session with either their preferred or non-preferred psychotherapy approach

4 weeks
1 psilocybin session, 2 preparation and integration sessions

Treatment Phase 2

Participants receive the second psilocybin session with the alternate psychotherapy approach

4 weeks
1 psilocybin session, 2 preparation and integration sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-centered psilocybin-assisted therapy
  • Music-centered psilocybin-assisted therapy
  • Psilocybin

Trial Overview

The study tests if personal preference for music or mindfulness influences the effectiveness of psilocybin-assisted psychotherapy in treating depression. It compares these two styles after participants rate their preference, aiming to improve mood and well-being.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Preferred treatmentExperimental Treatment3 Interventions
Group II: Non-preferred treatmentExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kyle Greenway

Lead Sponsor

Citations

Psilocybin-assisted group psychotherapy and mindfulness ...

This trial met its primary endpoint: group psilocybin-assisted therapy plus MBSR was associated with clinically significant improvement in depressive symptoms ...

Psilocybin-assisted group psychotherapy and mindfulness ...

After 2 weeks, participants who received mindfulness training plus group psilocybin-assisted therapy showed significantly greater reductions in depression ...

Understanding Music and Mindfulness Preferences in ...

Psilocybin-assisted psychotherapy (PAP) is an emerging treatment for Treatment-Resistant Depression (TRD) that pairs one or two doses of psilocybin, a ...

Psilocybin-Assisted Group Psychotherapy + Mindfulness ...

Group psilocybin-assisted therapy plus MBSR was associated with clinically significant improvement in depressive symptoms without serious adverse events.

Psychological flexibility as a mechanism of change in ...

Psychological flexibility, several facets of mindfulness, and values-congruent living significantly improved following psilocybin and were maintained through ...