Phase 3 Depression and Anxiety Trial, By Invitation
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who successfully completed either the CYB003-002 APPROACH or CYB003-003 EMBRACE trial and received both doses of the trial medication in that study.
- People who stayed on the same antidepressant medication at the same dose throughout the APPROACH or EMBRACE trial.
- People who are willing and able to give written consent to participate, including following all the requirements listed in the consent form.
- People who are capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their last dose, if their partner could become pregnant; that partner must also use a highly effective form of contraception (less than 1% failure rate when used correctly) for the same period.
- People of childbearing potential whose partner is capable of producing sperm must agree to use a highly effective form of contraception (less than 1% failure rate when used correctly) together with a condom plus spermicide (where publicly available) during the trial and for 12 weeks after the last dose.
- Female participants must have a negative pregnancy test at the start of this trial (which is the end-of-trial visit in APPROACH or EMBRACE) and again before receiving their dose on dosing day.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who developed new symptoms of schizophrenia or other psychotic disorders during the APPROACH or EMBRACE trial.
- People assessed as having a significant risk of suicide, based on specific scores on a standardised suicide risk scale (C-SSRS), or who experienced a suicide-related event or self-harm during the APPROACH or EMBRACE trial, or whose scores on that scale changed notably during APPROACH (confirm with trial site).
- People who had a clinically concerning irregular heartbeat or significant changes in vital signs (such as heart rate or blood pressure) during any dosing session in the APPROACH or EMBRACE trial.
- People who had clinically significant abnormal heart rhythm readings (ECG) during the APPROACH or EMBRACE trial or at the start of this trial.
- People who showed signs of a sensitivity or suspected sensitivity to the trial medication (CYB003) during the APPROACH or EMBRACE trial.
- People who test positive for drugs of abuse or alcohol immediately before a dosing session.
- People who are unwilling to consent to having their psychological support sessions and dosing sessions recorded by audio and video.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Montgomery-Asberg Depression Rating Scale (MADRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.