Status:
RECRUITING
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
Lead Sponsor:
Cybin IRL Limited
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT06605105
Start Date
July 18 2025
End Date
March 15 2028
Last Update
November 24 2025
Active Locations (10)
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1
Open Mind Collective / UCSF Medical Center - Mount Zion
San Francisco, California, United States, 94114
2
Research Centers of America
Hollywood, Florida, United States, 33024
3
Segal Trials Center for Psychedelic Research
Lauderhill, Florida, United States, 33319
4
Cenexel iResearcvh Atlanta, LLC
Atlanta, Georgia, United States, 30030