Phase 3 Depression and Anxiety Trial, 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 are veterans of the U.S. military and speak English.
- People who have signed the required consent and privacy forms.
- Adults aged 75 or younger.
- People who currently meet the clinical definition of a major depressive episode (a specific type of serious depression, as diagnosed using standard psychiatric guidelines).
- People whose depression scores at the start of the study are at or above a certain level, as measured by a standard rating scale (confirm with trial site).
- People whose depression has not responded well enough to at least 2 antidepressant treatments, each taken for at least 8 weeks (including at least 2 weeks at a high enough dose), for major depression — adding a second medication to boost a treatment counts as a separate treatment course.
- People who are currently taking permitted antidepressants must have been on a stable dose of those medications for at least 4 weeks before the study starts.
- People who are able to become pregnant must have a negative pregnancy test and must agree to use an appropriate method of birth control throughout the study.
- People who have a responsible adult available to drive them home or to their lodging on the days they receive the study treatment.
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 ever been diagnosed with bipolar disorder, schizophrenia, or any other psychotic disorder.
- People who have a parent, sibling, or child with a history of bipolar I disorder, schizophrenia, or another psychotic disorder.
- People who are currently experiencing symptoms of psychosis (such as a depressive episode that includes psychotic symptoms).
- People who have had a problem with misuse of sedatives, sleeping pills, stimulants, inhalants, or opioids in the past 6 months.
- People who have had a severe problem with alcohol or cannabis use in the past 6 months.
- People who have ever experienced lasting visual disturbances caused by hallucinogens, or who have ever had a hallucinogen use disorder.
- People who have used psilocybin, ayahuasca, mescaline, LSD, DMT, 5-MeO-DMT, peyote, or MDMA in the past 6 months.
- People who do not agree to avoid using the psychedelic substances listed above during the study (except as given through the study itself).
- People who have taken a prohibited medication within 2 weeks before the study start date (confirm with trial site for the full medication list).
- People with a history of severe traumatic brain injury.
- People who have been diagnosed with dementia or a similar condition that causes progressive decline in memory and thinking.
- People who have had certain serious levels of suicidal thoughts or behaviour in the past 6 months, as measured by a standard assessment tool (confirm with trial site).
- People who have been admitted to a psychiatric hospital in the past 3 months.
- People who have received electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within the past 3 months.
- People who have a device implanted in their brain or nervous system.
- People who are currently receiving, or have received within the past 2 weeks, a specific type of structured psychological therapy for depression or PTSD — this therapy must have ended at least 2 weeks before the study starts (other types of non-structured therapy for these conditions may be allowed to continue).
- People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the active treatment part of the study.
- People with a history of heart attack, heart failure, diabetic ketoacidosis, brain cancer, stroke, or other serious heart disease.
- People with a significant heart, lung, kidney, liver, or other medical condition that, in the investigator's judgement, could make taking psilocybin unsafe or could affect the study results.
- People with a seizure disorder, except for seizures caused by fever or substance withdrawal.
- People with significantly high blood pressure, low blood pressure, a fast resting heart rate, a certain type of abnormal heart rhythm reading, or other clinically significant heart rhythm problems on an ECG (confirm with trial site for specific thresholds).
- People with significantly abnormal results on blood tests checking organ function, blood cell counts, or thyroid levels.
- People who test positive for illicit drugs (other than cannabis/THC) on a urine drug screen at the time of screening or at the study start.
- People who have previously had an allergic reaction or a bad reaction to a psilocybin product.
- People who are currently involved in legal action seeking disability payments for a mental health condition outside of the standard VA compensation and assessment process.
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: Lori Lynne Davis, MD AB, Birmingham VA Medical Center, Birmingham, AL
Phone: (205) 554-3819
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
Montgomery-Asberg Rating Scale (MADRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.