Phase 3 Depression and Anxiety Trial, Not Yet Recruiting
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 aged between 12 and 19 years.
- People who have been diagnosed with a Major Depressive Episode (a single, non-bipolar type of depression) using a structured clinical interview and standard diagnostic guidelines (DSM-5), carried out by experienced evaluators.
- People who are already receiving standard treatment for their depression — which may include medication and/or talking therapy — at one of the two participating clinics (DICA or Conversas de Vida / Unifesp).
- People whose depression scores at least 25 on a clinician-rated scale called the MADRS (a tool used by doctors to measure how severe depression is).
- People whose depression scores at least 28 on another clinician-rated scale called the CDRS (a similar tool designed for children and young people).
- People who score at least 2 on the Columbia Suicide Severity Rating Scale (C-SSRS), which is a tool used to assess suicidal thoughts and behaviours.
- People who have made a suicide attempt, or have had serious thoughts or plans of suicide requiring emergency assessment, within the last 30 days.
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 have been diagnosed with Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, a psychiatric condition caused by a physical illness, or who have a history of ketamine or other substance misuse or dependence in the last 6 months.
- People who have an Intellectual Disability, as assessed by IQ testing.
- People who have a history of certain serious physical health conditions, including heart attack, congenital heart disease, uncontrolled irregular heartbeat, uncontrolled high blood pressure, porphyria, stroke, a brain injury involving loss of consciousness, raised pressure in the skull, hydrocephalus, brain or spinal cord tumours, or other abnormalities of the central nervous system.
- People who have previously been treated for depression with the medication esketamine.
- People who have a known allergy to esketamine.
- People who are pregnant or breastfeeding.
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
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- 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
Primary endpoints
Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score at 24 Hours Post First Dose
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.