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

Enrolling By InvitationPhase 3

Sponsor: Cybin IRL Limited

Conditions: Major Depressive Disorder

Interventions: CYB003

Countries: United States, Australia

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 overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (33)

Phoenix, Arizona, United States
San Francisco, California, United States
San Juan Capistrano, California, United States
Denver, Colorado, United States
Evergreen, Colorado, United States
Hollywood, Florida, United States
Lady Lake, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Skokie, Illinois, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Las Vegas, Nevada, United States
New York, New York, United States
The Bronx, New York, United States
Canton, Ohio, United States
Memphis, Tennessee, United States
DeSoto, Texas, United States
Houston, Texas, United States
Draper, Utah, United States
Camperdown, New South Wales, Australia
Maroochydore, Queensland, Australia
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