Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) (EXTEND)

This open-label, Phase III long-term extension trial (n=220) aims to assess the safety and long-term efficacy of psilocybin (CYB003) in participants with major depressive disorder (MDD). Participants will receive up to three doses of 16 mg of CYB003, administered in medicine sessions approximately three weeks apart.

The study follows participants from the previous double-blind trial, APPROACH (CYB003-002), to evaluate the effects of additional doses of CYB003.

Non-responders from the initial trial or those who relapse will be eligible for treatment while continuing their current antidepressant regimen and receiving psychological support. The primary outcome will be measured using the Montgomery–Åsberg Depression Rating Scale (MADRS) at multiple time points throughout the study. Sponsored by Cybin in collaboration with Worldwide Clinical Trials, this trial is set to begin in February 2025 and is expected to be completed by September 2027.

Topic Depression Safety
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 23 February 2025
End date 06 September 2027
Phase Phase III
Design Open
Type Interventional
Generation Second
Participants 220
Sex All
Age 18- 85
Therapy No

Trial Details

This is a long- term extension of the double-blind trial, APPROACH (CYB003-002). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

Trial Number NCT06605105

Sponsors & Collaborators

Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

Data attribution

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