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 22 years or older.
- People who are currently going through a depressive episode with at least moderate symptom severity, as measured by a standard depression rating scale (HAM-D17 score of 17 or higher).
- People who have tried at least one antidepressant medication during their current or a previous depressive episode, but either did not get enough relief from it or could not tolerate the side effects.
- People who, for the 6 weeks before joining the trial, have either not been taking any antidepressant medication, or have been on a stable psychiatric medication routine without any dose changes.
- People who are currently attending therapy focused on depression and have kept to the same therapy schedule for at least 8 weeks before joining, and who agree to continue that same schedule throughout the trial.
- People who are able and willing to follow the trial schedule and procedures, in the view of the trial investigator.
- People who understand English and are able to give written consent to participate.
- People who are currently under the care of a psychiatrist or primary care doctor for major depressive disorder, and who agree to promptly let study staff know if they change their mental health provider during the trial.
- People who agree to allow the study team to communicate with their current or past (within the last 2 years) healthcare providers.
- People who can provide names and verifiable contact details for at least two people aged 18 or older who live within a 60-minute drive of their home, so that research staff can contact those people if needed to ensure the participant's safety during 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 used an external brain stimulation device for depression in the past six months or currently, including treatments such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or similar brain or nerve stimulation treatments.
- People who have ever had a full course of ECT, TMS, or implanted vagus nerve stimulation and did not respond to it.
- People who are currently receiving esketamine, ketamine, or psilocybin treatment.
- People who are pregnant, or who are capable of becoming pregnant and are not using adequate contraception, as determined by the investigator.
- People who are currently breastfeeding.
- People whose current depressive episode began within 6 months after giving birth.
- People who have an active skin condition on their forehead that, in the investigator's opinion, could be made worse by the placement of stimulation electrodes.
- People who have clinical features or personal history that, in the investigator's opinion, make them unsuitable for this trial.
- People whose current depressive episode has not improved after three or more adequate trials of antidepressant medications approved by the FDA.
- People who currently have thoughts of suicide with a plan or intention to act on them, or who have made preparations for or attempted suicide in the past 3 months, as assessed by a standard safety tool or the investigator.
- People who have a history of epilepsy or unexplained seizures, as determined by the investigator.
- People who have a diagnosis or history suggesting bipolar disorder, hypomania, mania, or psychosis, as determined by the investigator.
- People who are currently taking part in, or planning to take part in (within the next 3 months), another study involving an experimental drug or device that, in the investigator's opinion, could affect depression symptoms or interfere with the trial device.
- People who have had brain surgery in the past.
- People who have implanted nerve stimulators, permanent or implanted electrical devices, or metal objects inside the skull (dental metal is excepted).
- People who have cognitive difficulties or memory disorders that, in the investigator's opinion, could affect their ability to follow the study requirements.
- People who currently meet the diagnostic criteria for obsessive compulsive disorder.
- People who meet clinical criteria for moderate or severe alcohol use disorder or other substance use disorders (not including tobacco or nicotine) within the past 6 months, as confirmed by a structured clinical interview.
- People who meet clinical criteria for moderate or severe cannabis use disorder within the past 6 months, as confirmed by a structured clinical interview (people with recreational or medical cannabis use that does not reach the level of moderate or severe cannabis use disorder are not excluded).
- People who have a current neurological condition or disease that, in the investigator's opinion, is likely to produce depression-like symptoms that would make it difficult to accurately diagnose or monitor major depressive disorder during the trial.
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.
Contact this trial
Principal Investigator: Mark George, MD, Medical University of South Carolina
Phone: 910-447-6576
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
Hamilton Depression Rating Scale (HDRS) score reduction, Phase 1 Evaluation
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.