EXTEND - CYB003-004
Research type
Research Study
Full title
A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-Term Efficacy in Participants with Major Depressive Disorder (EXTEND Trial)
IRAS ID
1011760
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. It is a type of psychedelic medication similar to psilocybin (the active ingredient in Psilocybe mushrooms). CYB003 and psilocybin, at certain doses, cause an altered state of consciousness or make people see or hear things that are not real. When combined with psychological support, CYB003 and other psychedelics may support deeper access to inner thoughts and healing. CYB003 is being tested to see if it can treat major depressive disorder (MDD).
This trial is a long-term follow-up of the EMBRACE (CYB003-003) trial and will try to find out:
• If CYB003 works, i.e., if CYB003, along with psychological support, can improve symptoms of MDD over a long period of time.
• If CYB003 is safe, i.e., what side effects CYB003 causes and how bad they are.
The participants will be eligible for dosing if their symptoms did not improve during the EMBRACE trial or their symptoms improved, but they are now experiencing them again in this trial. If at any point of the trial, participants meet the requirements for dosing, they will receive CYB003 (16 mg) as an oral capsule at the trial clinic on different days. CYB003 can be given up to 3 times during this trial, depending on symptoms. If the participants do not meet the requirements for dosing, they will not receive CYB003 and will only be followed-up in this trial.
The trial population will include up to 550 men and women aged 18 to 85 years, with a confirmed diagnosis of MDD who have completed the 12-week double-blind treatment trial, in other studies with CYB003.
This trial is open-label which means that all participants who meet the requirements for dosing will get CYB003 (16 mg). Participants will be in this trial for about 10 months (43 weeks) if they stay in the trial until the end. There will be a total of up to 29 visits (up to 15 trial clinic visits and up to 14 remote visits; remote visits will be done using an appropriate video-conferencing system).REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0154
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Favourable Opinion