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
- Bialystok, Bydgoszcz, Gdansk, and Warsaw, PolandSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depressive disorder who finished the earlier CYB003 trials APPROACH or EMBRACE. It follows their long-term safety and results.
- Age
- 18 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder.
- Earlier treatment
- Must have finished CYB003-002 APPROACH or CYB003-003 EMBRACE and had both dose administrations of the trial medication. Must have stayed on the same antidepressant at a stable dose throughout that trial.
Main reasons for not taking part
- New symptoms of schizophrenia or other psychotic disorders in the earlier trial
- Significant suicide risk, or suicidal thoughts or self-harm events in the earlier trial
- Heart rhythm problems, vital sign changes or ECG abnormalities seen in the earlier trial or at baseline
- Sensitivity or suspected sensitivity to CYB003 in the earlier trial
- Positive test for drugs of abuse or alcohol before dosing
Read by machine on 9 November 2026.
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 Poland
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandTaking people
- PROMENTE Sp. z o.o.Bydgoszcz, PolandTaking people
- Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Instytut Psychiatrii I NeurologiiWarsaw, PolandTaking people
- MTZ Clinical Research powered by PratiaWarsaw, PolandTaking people
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.