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

Launched by CYBIN IRL LIMITED · Sep 17, 2024

Keywords

ClinConnect Summary

The EXTEND trial is a long-term study that looks at the safety and effectiveness of a medication called CYB003 for people with Major Depressive Disorder (MDD). This trial is an extension of two previous studies and aims to see how well the medication works over a longer period. If you're between the ages of 65 and 74 and have participated in either of the earlier studies (APPROACH or EMBRACE) without major issues, you might be eligible to join.

In this trial, participants will continue taking their usual antidepressant medication and receive CYB003, while also providing consent to have their sessions recorded for study purposes. It's important to note that those with significant suicide risks or certain other conditions may not be eligible. The trial is not yet recruiting participants, so you’ll need to keep an eye out for when it starts. Overall, this study is an opportunity to help researchers learn more about treating depression effectively and safely over time.

Gender

ALL

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