Phase 1 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
- The person has signed a written consent form agreeing to take part in the trial.
- The person has been diagnosed with Major Depressive Disorder (a serious form of depression) according to standard psychiatric guidelines known as DSM-5.
- The person scored 28 or higher on a depression rating scale called the MADRS at the screening appointment, indicating a high level of depression symptoms.
- The person can read, write, and speak English fluently.
- Study team doctors have assessed the person as being at low risk of suicidal thoughts or behaviour.
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.
- Women who are pregnant, breastfeeding, or not using an effective form of contraception.
- People with certain heart or blood vessel conditions, including high blood pressure (resting blood pressure above 139/89), angina (chest pain from the heart), a heart rate above 99 beats per minute, a significant abnormal heart rhythm or electrical reading on an ECG (such as atrial fibrillation), a mini-stroke in the last 6 months, stroke, disease of the blood vessels in the limbs or lungs, or problems with the heart valves.
- People who have epilepsy.
- People with insulin-dependent diabetes, or people taking oral diabetes medication who have a history of low blood sugar episodes.
- People who are currently taking antipsychotic medications or a type of antidepressant called MAO inhibitors.
- People who are taking antidepressant medications and are unable to gradually reduce and stop them before the trial.
- People whose current antidepressant is a moderate or strong CYP2D6 inhibitor (a specific drug type — confirm with trial site) must have stopped taking it for at least 4 weeks or five half-lives before treatment begins.
- People who are currently taking a CYP2D6 inhibitor medication (a specific drug type — confirm with trial site) for a reason other than depression, and which cannot be tapered.
- People currently taking any of the following medications: efavirenz, disulfiram (Antabuse) or similar drugs that affect how the body processes alcohol, alcohol dehydrogenase inhibitors, or certain other specific drugs including phenytoin, regorafenib, or eltrombopag (confirm with trial site for full list).
- People with a seizure disorder, multiple sclerosis, a significant past head injury, a tumour affecting the brain or nervous system, movement disorders, or any condition causing progressive decline in brain function.
- People who are classified as morbidly obese, meaning more than 100 pounds over their ideal body weight, or a BMI of 40 or above, or a BMI of 35 or above combined with high blood pressure or diabetes.
- People whom a study team doctor judges to be at risk of moderate or severe withdrawal from alcohol or benzodiazepine medications.
- People who weigh less than 45 kilograms.
- People who have had a significant serious reaction (such as severe involuntary muscle movements) to an antipsychotic medication in the past.
- People who currently meet, or have previously met, the DSM-5 diagnostic criteria for Schizophrenia, a Psychotic Disorder (including one caused by substance use), Bipolar I or II Disorder, or Major Depression with psychotic features.
- People who have a parent, sibling, or child diagnosed with Schizophrenia, a Psychotic Disorder (unless it was caused by substance use or a medical condition), or Bipolar I Disorder.
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.
Contact this trial
Principal Investigator: Sandeep Nayak, MD, Johns Hopkins University
Phone: 917-991-0642
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
Where this trial is recruiting
Primary endpoints
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.