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

Enrolling by invitation · Phase 3

Conditions studied: Major Depressive Disorder

In brief

This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

Key facts

Study ID

NCT06605105

Run by

Cybin IRL Limited

People needed

468

Starts

2025-07-18

Expected to finish

2028-03-15

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication
• Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE
• Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form
• Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP
• Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP
• Female participants must have a negative pregnancy test at Baseline (the end of trial [EOT] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day

You may not qualify if…

• newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial
• Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation/attempt or self-harm in CYB003-002 APPROACH OR has had a >1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH
• Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial
• Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND
• Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial
• Positive urine test for drugs of abuse, or alcohol breath test prior to dosing.
• Unwilling to consent to audio and video recording of psychological support and dosing sessions

Where it is running

• Combined Research Orlando — Phoenix, Arizona, United States
• Open Mind Collective / UCSF Medical Center - Mount Zion — San Francisco, California, United States
• Inland Psychiatric Medical Group Inc (IPMG Research) — San Juan Capistrano, California, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Starlight Clinical Research — Evergreen, Colorado, United States
• Research Centers of America — Hollywood, Florida, United States
• K2 Medical Research — Lady Lake, Florida, United States
• Segal Trials Center for Psychedelic Research — Lauderhill, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Charter Research — Orlando, Florida, United States
• Cenexel iResearcvh Atlanta, LLC — Atlanta, Georgia, United States
• Atlanta Center For Medical Research — Atlanta, Georgia, United States
• CenExel iResearch — Savannah, Georgia, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Psychiatric Medicine Associates, LLC — Skokie, Illinois, United States
• Psychiatric Medicine Associates — Skokie, Illinois, United States
• Sunstone Medical, PC — Rockville, Maryland, United States
• Adams Clinical Boston — Boston, Massachusetts, United States
• Adams Clinical — Watertown, Massachusetts, United States
• Redbird Research — Las Vegas, Nevada, United States
• Adams Clinical Harlem — New York, New York, United States
• Adams Clinical Bronx — The Bronx, New York, United States
• Neurobehavioral Clinical Research — Canton, Ohio, United States
• Clinical Neuroscience Solutions, CNS Healthcare — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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