Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled 688 people in total across three groups: 228 received quetiapine XR on its own (as a single treatment, referred to as "Mono"), 231 received quetiapine XR added on top of another existing treatment, and 229 received lithium added on top of another existing treatment. The trial ran for six weeks and was measuring changes in depressive symptoms in people who had not responded well to previous antidepressant treatments. Symptoms were tracked using a standardised depression rating scale called the MADRS, which runs from 0 to 60, where a lower score indicates fewer depressive symptoms. The reported data shows that, after six weeks, all three groups had lower (improved) MADRS scores compared to when they started. Using one method of analysis (called the "per protocol" set, which looks at people who closely followed the trial plan), the reported average score reductions were: minus 16.2 points for the quetiapine XR alone group, minus 17.2 points for the quetiapine XR add-on group, and minus 14.9 points for the lithium add-on group. Using a second method of analysis (called "modified intention to treat," which includes a broader group of participants), the reported average reductions were: minus 13.9, minus 15.1, and minus 13.3 points respectively. The reported data also shows the number of participants whose scores fell to 10 or below — a threshold the trial used to define "remission" (meaning very low depressive symptoms): 53 people in the quetiapine XR alone group, 73 in the quetiapine XR add-on group, and 60 in the lithium add-on group reached that threshold. When a stricter cut-off of 8 or below was applied, the numbers were 35, 58, and 45 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Depression and Anxiety Trial, Completed
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
- You have been officially diagnosed with Major Depressive Disorder (MDD) — either a single episode or a recurring episode — confirmed using a standard diagnostic interview tool
- Your current episode of depression started at least 42 days before joining the trial, but no more than 18 months ago
- Your depression symptoms score at least 25 points on a standard rating scale called the MADRS, both when you first enrol and when you are officially assigned to a treatment group
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.
- You have been diagnosed with another major mental health condition (other than MDD) within the 6 months before joining the trial (confirm with trial site)
- You have a diagnosed personality disorder or similar condition that is significantly affecting your current mental health status (confirm with trial site)
- In the doctor's judgement, you are currently at serious risk of harming yourself or others, or you have attempted suicide in the past 6 months
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 was run
These are the locations recorded on the registry, including 11 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set); Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
Other options
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.