Investigational treatment for Psilocybin therapy

Exploring potential routes away from treatment-resistant depression

Efficacy, Safety, and Tolerability of Two Administrations of Synthetic Psilocybin in Participants With Treatment-Resistant Depression (TRD)
Age - 18 years +
Depression Diagnosis
The Compass Pathfinder studies are looking into a potential new approach for people with TRD using an investigational medicine, called psilocybin therapy or psilocybin treatment, given with psychological support. The study is suitable for people who have been diagnosed with major depression and are currently experiencing a recurrent or single episode of depression and have not responded to antidepressant treatment.

Study Overview:

Condition
Depression
Modalities
Complementary and alternative medicine (CAM), Neuropharmacological/Neuropsych Agents
Intervention
Psilocybin / psilocybine
Primary Investigator
COMPASS Pathways
This is a  Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Eligibility Criteria

Participant criteria for eligibility in this study.
*Even if you may not meet all the criteria, feel free to reach out using the Join Study button

Key Inclusion Criteria:

  1. You must be 18 years or older.
  2. You must have a diagnosis of Major Depressive Disorder without psychotic features.
  3. The duration of your current depressive episode must be greater than 3 months and less than 2 years.
  4. This trial will be looking for treatment-resistant depression, which is defined as not responding to an adequate dose of 2 or more different psychiatric medications.
  5. You will need to slowly taper and discontinue your current antidepressant regimen (the Principal Investigator and psychiatrist Dr. Ranji Varghese will facilitate this).

Key Exclusion Criteria:

  1. If you have a prior or ongoing diagnosis of bipolar disorder, psychotic disorder that includes schizophrenia, schizophreniform disorder, schizoaffective disorder, or antisocial personality disorder.
  2. If you have a lifetime diagnosis of certain personality disorders including narcissistic, histrionic, schizoid, paranoid, schizotypal or any serious psychiatric comorbidity based on our medical history and clinical judgment.
  3. If a structured clinical interview demonstrates borderline personality disorder.
  4. If you have ongoing posttraumatic stress disorder symptoms, obsessive-compulsive disorder symptoms, or anorexia nervosa as assessed by clinical history and structured interview.
  5. If you have been psychiatrically hospitalized within the past 12 months.
  6. If you have had electroconvulsive therapy, deep brain stimulation or vagus nerve stimulation during the current depressive episode
  7. If you have had transcranial magnetic stimulation within the past 6 months.
  8. If you are currently enrolled in a psychological therapy program (CBT, psychotherapy) that you plan to discontinue for the duration of the study
  9. Use of COMP360 Psilocybin medicine in the past.

Participant Commitment

This section outlines the commitment required for this study.
  • This study will require a commitment of up to 1 year (62 weeks total)
  • Participants will be available for up to 30 appointments. 
  • Willing to and able to make regular in-person visits to the trial site location.
  • In-person treatment visits will last between 7—8 hours.

How to sign up for this study

  1. Follow the link below to 'sign up' for inquiring study participants.
  2. Submit your contact information and a medical records request through SiteRx for the inital study eligibility review.

    SiteRx will securely handle medical record retrieval. No uploading required!
  3. Following record submission, a research study coordinator will reach out for an initial study screening call.
Sign up now!
*To move forward in the screening process, we’ll need access to your medical records. The link above will take you to SiteRx, a secure, HIPAA-compliant platform we use to request and retrieve those records on your behalf. This step is required as part of determining your eligibility for the study, and completing it early helps avoid delays.

Contact Us and Learn More

Email: [email protected]
Phone: (651) 280–8774

Important Study Links:

ClinicalTrials.gov ID: NCT05711940 
https://clinicaltrials.gov/study/NCT05711940
Compass Pathways Study Overview
https://compasspathways.com/our-work/treatment-resistant-depression/
COMPASS Pathways
https://compasspathways.com/