Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
NCT ID: NCT06605105
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
468 participants
INTERVENTIONAL
2025-07-18
2028-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CYB003
Initial non-responders in CYB003-002 APPROACH and CYB003-003 EMBRACE, or initial responders who later relapse will be eligible to receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. If a participant relapses again, the participant may receive an additional single 16mg of CYB003 (maximum of 3 16mg doses in CYB003-004 EXTEND). Participants will continue on their current antidepressants and receive psychological support throughout the study.
CYB003
CYB003 is a deuterated psilocin analog
Interventions
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CYB003
CYB003 is a deuterated psilocin analog
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Worldwide Clinical Trials
OTHER
Cybin IRL Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_CHAIR
Cybin IRL Limited
Locations
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Open Mind Collective / UCSF Medical Center - Mount Zion
San Francisco, California, United States
Research Centers of America
Hollywood, Florida, United States
Segal Trials Center for Psychedelic Research
Lauderhill, Florida, United States
Cenexel iResearcvh Atlanta, LLC
Atlanta, Georgia, United States
Atlanta Center For Medical Research
Atlanta, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Sunstone Medical, PC
Rockville, Maryland, United States
Adams Clinical
Watertown, Massachusetts, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CYB003-004
Identifier Type: -
Identifier Source: org_study_id
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