A Phase 3 Trial to Assess CYB003 (Psilocybin Analog) in Major Depressive Disorder

OPENING SOON

Sunstone is recruiting participants for a phase 3, randomized, and double-blind trial to assess the efficacy and safety of CYB003 (psilocybin) in adults with Major Depressive Disorder (MDD).

Introduction and Rationale for Study

Depression (major depressive disorder) is serious medical illness that negatively affects how you feel, the way you think, and how you act. Depression is a leading contributor to the global burden of disease affecting millions of adults.  

Although there are medications to address MDD, a significant amount of patients do not adequately respond to available treatments. Psilocybin is an alternative treatment to traditional antidepressant medications that has shown promise in multiple clinical trials. This trial uses CYB003, a synthetic, deuterated isotopomer of psilocin, the active metabolite of psilocybin, that has a shorter duration of psychedelic effects. 

This research seeks to continue exploring the therapeutic value of this type of treatment.

Purpose and Description

This trial aims to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

This trial is enrolling participants who are currently taking a stable dose of a single antidepressant medication and does not require participants to taper off of their antidepressant medication.


The study involves the following study visits including but not limited to:

  • Three (3) Preparatory Session
  • Two (2) Dosing Sessions*
  • Six (6) Post-dose Sessions
  • Follow-Up for 6 weeks post dosing (in-person and virtual appointments)

*Non-responders may be eligible to receive CYB003 in a subsequent extension trial

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. 
  • Eligible participants will be randomized in a 1:1 ratio to receive 2 oral administrations of study drug or placebo. Participants, research staff, and therapists are all blinded. 
  • All in-person visits take place at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD. 
  • Study drug will be administered in a safe setting with constant support from trained and experienced therapists. The support includes careful preparation before the experience and processing after the experience. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial. 
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

To inquire about participation in the Cybin CYB003 Study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/study/NCT06564818?term=cybin&rank=2