Long-term safety study of CYB003 in adults with major depression
Tests CYB003 over the long term in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
Key facts
- Where
- Berlin, Frankfurt Am Main, Homburg, and Mannheim, GermanySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06605105, who can take part
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting
- Universitaetsklinikum des Saarlandes AöRHomburg, GermanyNot yet recruiting
- Zentralinstitut Fuer Seelische GesundheitMannheim, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cybin IRL Limited
- Trial code
- NCT06605105EU 2024-516805-22-00
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)
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.
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: Positive urine test for drugs of abuse, or alcohol breath test prior to dosing; newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial; Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions 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; 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; Unwilling to consent to audio and video recording of psychological support and dosing sessions.