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

About

This is a Phase 3 clinical trial exploring CYB003, a next-generation psilocybin-based investigational treatment. This study is designed to assess the safety and effectiveness of CYB003, combined with professional therapeutic support, for people struggling with depression.

Enrollment Status & Timeline

Enrollment is currently open. Participation lasts approximately 4.5 months, with a combination of in-person and virtual visits.

Location

This study will be conducted at InnerMost, in NoMad, Manhattan, New York City.

Eligibility

Adults (18–85 years old) living with Major Depressive Disorder (MDD) who are currently taking an antidepressant but continue to experience symptoms.

You may be eligible if you:
- Are between 18–85 years old
- Have been diagnosed with Major Depressive Disorder
- Are currently taking an antidepressant
- Can attend in-person visits at our Manhattan-based clinic

Cost

All study-related care and medication are provided at no cost, and participants are compensated for time and travel.

Safety & Support

Every dosing session takes place in a supportive environment with trained, experienced professionals. Safety is a priority—participants are carefully monitored throughout, and integration support is provided after each experience.

What to Expect

This study will be conducted under the guidance of Dr. Casey Paleos, MD in Manhattan, NY. Participants will receive:
- 3 preparatory sessions
- 2 dosing sessions (CYB003 or placebo, randomized and blinded)*
- 6 integration sessions after dosing
- 6 weeks of follow-up care (in-person and virtual)

*Participants who do not initially receive the investigational treatment may have the opportunity to take part in an extension study with CYB003.

What Participation Involves

Participants in this trial will:
- Continue their current antidepressant medication (no tapering required)
- Take part in a randomized, double-blind trial (neither participants nor staff know whether CYB003 or placebo is given)
- Receive guided preparation, dosing, and integration support throughout the process

Why this Study Matters

Depression is one of the leading causes of disability worldwide, and many individuals do not respond fully to current medications. Research into psilocybin has shown promise as a novel therapeutic option. CYB003 has been designed to provide potential benefits with a shorter and more predictable psychedelic experience.

For more information about this study, click here.