Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cybin IRL Limited
With
Worldwide Clinical Trials
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
