Phase 4 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
- Adults aged 18 to 65 years old (inclusive).
- People who have been diagnosed with depression for the first time, or who have experienced a return of depression, meeting specific recognised diagnostic standards (DSM-5).
- People whose depression is rated as moderately severe or above on a standard depression rating scale (a score of 18 or higher on the Hamilton Depression Scale, HAMD-17) at the time of joining.
- People who have not taken antidepressant medications in the 2 weeks before joining the trial (or 6 weeks for the specific antidepressant fluoxetine).
- People who are willing to read and sign a consent form agreeing to take part in the trial.
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 other mental health conditions in addition to depression, such as schizophrenia, bipolar disorder, or obsessive-compulsive related disorders, among others.
- People whose depression has not responded to at least two different antidepressant treatments given at adequate doses, as assessed or previously recorded by the investigating doctor.
- People considered by the investigating doctor to be at significant risk of suicide, including those with a score of 3 or higher on the suicide item of the Hamilton Depression Scale, or those who have made a suicide attempt in the past year.
- People who have received certain non-medication treatments — such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or structured talking therapy (10 or more sessions) — in the 6 months before joining.
- People who have other serious long-term health conditions, such as severe thyroid disease, Parkinson's disease, cancer, epilepsy, or severe rheumatic disease.
- People who have clinically significant heart abnormalities shown on a heart trace (ECG), including signs of heart attack, severe irregular heart rhythm, or certain electrical timing abnormalities in the heart (confirm with trial site for specific thresholds).
- People with severely reduced liver or kidney function, based on specific blood test results being above set thresholds (confirm with trial site for exact values).
- People who are allergic to the trial medication or any of its ingredients.
- People who are breastfeeding, able to become pregnant, or planning a pregnancy during the trial period.
- People with dependence on alcohol or drugs.
- People who are currently taking part in, or who have taken part in, another clinical trial within the past month.
- People considered unsuitable for participation by the investigating doctor due to potential risks or other factors.
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
Primary endpoints
Change in HAMD-17 score from baseline at Week 8.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.