Psilocybin-Assisted Psychotherapy for Depression

(PPP Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kyle Greenway

Must not be taking: Serotonin antagonists, MAO inhibitors

Disqualifiers: Psychosis, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how people respond to psilocybin treatment.

The main questions it aims to answer are:

* Is it feasible to conduct a patient-preference randomized trial of psilocybin-assisted psychotherapy?

* Does receiving a preferred psychotherapy style improve treatment experiences or outcomes?

* How do music-centered and mindfulness-centered PAP approaches compare in their effects on improving mood and well-being?

Researchers will compare music-centered PAP to mindfulness-centered PAP to see if aligning psychotherapy with individual preferences is a practical and potentially beneficial approach for improving treatment efficacy and tolerability.

Participants will:

* Be adults with treatment-resistant depression

* Receive two 25 mg psilocybin (PEX010, Filament Health) sessions, spaced four weeks apart

* Experience one session with music-centered psychotherapy and one with mindfulness-centered psychotherapy

* Before treatment, rate their preference for the two psychotherapy approaches

* Be randomly assigned to receive their preferred or non-preferred approach first, followed by the other

* Complete preparation and integration sessions before and after each psilocybin session

This feasibility trial will also collect information on participants' cultural and personal factors influencing psychotherapy preferences using a modified Cultural Formulation Interview, and explore physiological measures of therapeutic alliance, an important factor in psychotherapy outcomes.

Who Is on the Research Team?

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.

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.

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?

Group I: Preferred treatment Experimental Treatment 3 Interventions

Group II: Non-preferred treatment Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Kyle Greenway

Lead Sponsor