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 who have been diagnosed with Major Depressive Disorder (a type of depression without psychotic features) and are currently going through a depressive episode, as defined by standard psychiatric guidelines (DSM-5).
- People whose depression severity score on a standard rating scale (called the MADRS) is 20 or higher at the screening stage.
- People whose depression has not responded well to 2 or more antidepressant medications from at least 2 different medication types, during at least one depressive episode, as assessed using a formal treatment history tool.
- People who are willing and able to give written consent to participate in the trial.
- People between 22 and 85 years of age.
- People who are willing and able to follow the trial's requirements, including attending follow-up visits.
- People who have been on a stable psychiatric treatment plan for at least 30 days before the screening assessment and are willing to keep that treatment plan stable through the Week 4 follow-up visit.
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 a device implanted in the skull or body, such as a neurostimulator, implanted medication pump, spinal cord stimulator, or a pacemaker or heart device (dental implants are excepted).
- People who are expecting to need an MRI scan in the 12 months following a device implant.
- People who are unable to undergo certain types of brain imaging scans, including CT, MRI, DTI, or fMRI.
- People for whom, in the trial doctor's opinion, having the implant and receiving the therapy would carry an unacceptable surgical or medical risk.
- People who are currently taking blood-thinning medications and for whom stopping those medications is not possible.
- People who have taken ketamine or esketamine in the past 30 days, or who plan to take either medication before the 4-week follow-up visit.
- People who have taken hallucinogenic or dissociative medications in the past 30 days for mood or anxiety treatment, or who plan to take such medications before the 4-week follow-up visit.
- People who have a history of bipolar disorder.
- People who have a history of schizophrenia, schizoaffective disorder, or another psychotic disorder.
- People who are experiencing psychotic features as part of their current depressive episode.
- People who have a significant ongoing neurological condition such as epilepsy, dementia, delirium, memory disorders, or brain tumours, or whose brain imaging shows findings that could affect how well the treatment works (confirm with trial site).
- People who are currently taking medications that may lower the threshold for seizures, increasing seizure risk.
- People who have had a brain injury that has led to ongoing problems with memory or thinking.
- People who have a history of bone conditions that could affect the safe use or implantation of the device.
- People who have a history of skin conditions that could affect the safe use or implantation of the device.
- People whose depression did not improve by at least 50% after completing full approved courses of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS).
- People who plan to receive any other brain stimulation therapy (such as ECT, TMS, tDCS, tACS, DBS, VNS, or focused ultrasound) during the trial period.
- People who meet standard diagnostic criteria for alcohol use disorder or another substance use disorder (not including tobacco or nicotine) within the 12 months before joining the study, or who, in the trial doctor's opinion, are using substances in a way that could affect the safety or effectiveness of the treatment.
- People who are pregnant at the time of joining the trial, who plan to become pregnant during the study, or who are not willing to use an effective method of birth control.
- People whose life expectancy is less than 12 months.
- People who, in the trial doctor's opinion, are considered to be at acute risk of suicide (for example, scoring at a high level on a standard suicide risk scale).
- People who, in the trial doctor's opinion, have any other known health condition that could make it difficult to assess safety or attend follow-up visits.
- Before the device is implanted, people must still meet all of the trial's eligibility requirements, their psychiatric treatment plan must have remained stable, and their skull thickness over the implant site must be within a specific range (confirm with trial site).
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Esther Elliott, Alithia Life Sciences
Phone: 201-381-1534
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Incidence of device and/or procedure-related adverse events (AEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.