Investigational treatment IN Psilocybin therapy 

Introducing the EMBRACE clinical trial

Efficacy, Safety, and Tolerability of Two Administrations of Synthetic Psilocybin in Participants With Major Depressive Disorder (MDD)
Adults aged 18 - 85
Depression Diagnosis

About This Clinical Trial

The EMBRACE trial is exploring an investigational psychedelic substance, combined with
psychological support while you stay on your current antidepressant, to learn how effective
it might be at reducing symptoms of Major Depressive Disorder (MDD). 
The investigational study medicine will be combined with several psychological support sessions with a licensed therapist who has training in EMBARK, a psychological support model for MDD. You would also continue taking your current antidepressant medication.
It is hoped that the investigational study medicine given with psychological support may help people reach deeper into their thoughts to promote healing and potentially treat MDD.
Our clinic has helped hundreds of individuals in Minnesota and across the Midwest find relief from conditions that often feel unrelenting.

Study Overview:

Condition
Major Depressive Disorder
Recruitment Status
Recruiting
Intervention
CYB003-003
Principal Investigator
Manoj Doss, DO
An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder

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. Participant must be 18 to 85 years of age.
  2. Participant has a diagnosis of MDD.
  3. Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to screening.
  4. Participants with well controlled hypertension.

Key Exclusion Criteria:

  1. Current or previously diagnosed schizophrenia spectrum or other psychotic disorders.
  2. Significant suicide risk within 12 months of Screening.
  3. Current or previous diagnosis of treatment-resistant MDD.
  4. Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.
  5. Unwilling to consent to audio and video recording of psychological support and dosing sessions.

Participant Commitment

This section outlines the commitment required for this study.

  • Participation is expected to last about 4½ months.

  • 8 appointments at the clinic in-person

  • 8 remote appointments via video call

  • 9 psychological support sessions by video call or at the clinic

Appointments Overview

  • Screening

    2 clinic visits

    • 3 support sessions

    pre-dose

  • First dose

    2 clinic visits

    3 remote visits

    • 3 support sessions

    pre-dose

  • Second dose

    2 clinic visits

    3 remote visits

    • 3 support sessions

    pre-dose

  • Follow-up

    2 clinic visits

    2 remote visits

How to Join Studies at IIT

  1. Follow the link below to 'sign up' for inquiring study participants.
  2. After completion of criteria questions, please enter in your contact information and submit the form.
  3. Following submission a research study coordinator will reach out for an inital study screening call.
See if You're Eligible

Contact Us and Learn More

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

Important Study Links:

*Note that Cybin has been rebranded to Helus Pharma in January of 2026
ClinicalTrials.gov ID:  NCT06793397
https://clinicaltrials.gov/study/NCT06793397
Helus Pharma Clinical Trials
https://www.helus.com/clinical-trials/
Helus Pharma (previously Cybin)
https://www.helus.com/