A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Conditions

• Depression
• Depression - Major Depressive Disorder
• Depression Disorder
• Depression Disorders
• Depression in Adults
• Major Depressive Disorder (MDD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• CYB003 — DRUG
  CYB003 is a deuterated psilocin analog.
• Psychological Support — BEHAVIORAL
  Manualized psychological support performed by facilitator.

Study Details

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Key Dates

Start date

Dec 10, 2025

Status verified

Feb 2026

Primary completion

Mar 18, 2027

Completion

May 8, 2027

Study Design

Enrollment

330 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm A CYB003 in 2 of 2 Dosing Sessions
  Arm A participants will receive 8 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study.
• Experimental: Experimental Arm B CYB003 in 2 of 2 Dosing Sessions
  Experimental Arm B participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study.
• Placebo Comparator: Placebo Comparator: Arm C Placebo in 2 of 2 Dosing Session
  Participants will receive placebo in 2 of 2 medicine sessions, approximately three weeks apart. All Arm C participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial.

Primary Outcome Measure

Montgomery-Asberg Depression Scale (MADRS) [ Time Frame: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial. ]

Central Contacts

• Clinical Development
  877-361-4003
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

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