EMBRACE - CYB003-003
Research type
Research Study
Full title
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 (EMBRACE)
IRAS ID
1011630
Contact name
Amir INAMDAR
Contact email
Sponsor organisation
Cybin IRL Limited
Clinicaltrials.gov Identifier
Research summary
This trial will test an investigational medication called CYB003, a type of psychedelic medication similar to psilocybin. CYB003 is being tested to see if it can treat major depressive disorder (MDD) in participants aged 18 to 85 years. There are many available medicines on the market to treat MDD, but up to 30% of patients do not benefit from these medications. This trial will compare CYB003 with placebo. The trial has 3 parts: Screening Period of 6.5 weeks (which includes Baseline Visit too), Treatment Period of 6 weeks, and Follow-up Period of 6 weeks. After the Follow-up Period, participants may have the option to enter a long term extension trial where everyone will receive CYB003 (no placebo) if they meet the criteria for being depressed.
Participants will have the same chance (i.e., 1 in 3 or 33.3%) of being put either in the CYB003 8 mg group, CYB003 16 mg group, or the placebo group. Participants will receive CYB003 (8 mg or 16 mg) or placebo as an oral capsule at the trial clinic on 2 different days (Day 1 and Day 22).
Cybin IRL Limited is sponsoring this multicenter study, with approximately 330 patients in approximately 48 study sites globally.
Patients will be required to attend hospital visits whereby study assessments will be performed. CYB003 is at a research stage, so
it may cause side effects that are not known at this time. Patients will be monitored throughout the study; participation is voluntary
and informed consent is mandatory.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0139
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Favourable Opinion