Printed from Voxsanity (voxsanity.com.au) — NCT07479550 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Depression and Anxiety Trial, Not Yet Recruiting
NCT07479550
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 25 to 65 years old at the time of screening.
- People who are able to read, understand, and sign or electronically confirm their consent before screening, and who are expected to follow the study procedures and report any problems to study staff.
- People who are fluent in English.
- People who are able to attend all scheduled study visits and take part in all remote data collection activities.
- People who have been in a stable psychotherapy arrangement for at least 4 weeks before joining the study, and who will be able to continue accessing mental health care throughout the study.
- People with a body mass index (a measure of weight relative to height) between 17 and 35.
- People who have a current diagnosis of Major Depressive Disorder (MDD) during an active depressive episode, confirmed by a qualified member of the study team using a structured clinical interview tool.
- People who are physically able to safely receive general anaesthesia, as determined by a standard medical classification system (ASA Class I or II, or Class III where the health limitation is directly caused by depression).
- People who agree to avoid all non-prescription medications, supplements, and herbal products for one week before psilocybin sessions and throughout the study, except those approved by study staff (such as paracetamol, anti-inflammatory pain relievers, and standard doses of vitamins and minerals).
- People who agree not to eat or drink anything after midnight on the night before each dosing day.
- People who agree not to drink alcohol for 48 hours before and 24 hours after each dosing session.
- People who agree not to use cannabis in any form for the entire duration of the study.
- People who are non-smokers, or who have not smoked for at least 6 weeks.
- People who can become pregnant and who agree to use highly effective contraception from the time they enter the trial through to the end of the study (confirm specific contraception requirements with trial site, as detailed methods are listed in the criteria).
- People who can become pregnant and who have a negative urine pregnancy test at screening and again immediately before each dosing session.
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 an ongoing legal claim or disability claim, such as a Workers' Compensation claim.
- People who are currently taking certain types of antidepressant medications, including TCAs, MAOIs, SSRIs, or SNRIs (certain other antidepressants may be permitted — confirm with trial site).
- People who are currently taking typical or atypical antipsychotic medications.
- People who are currently taking certain anti-seizure medications, such as valproate, topiramate, oxcarbazepine, or carbamazepine (gabapentinoids and lamotrigine may be permitted — confirm with trial site).
- People who are taking other substances linked to a risk of serotonin syndrome, including St. John's Wort, SAM-e, 5-HTP, lithium, dextromethorphan, linezolid, buspirone, efavirenz, or lorcaserin.
- People who are taking medications that may affect how psilocybin is processed by the body, including certain enzyme modulators, high-dose L-Methylfolate (7.5mg/day or more), or alcohol- or aldehyde-related inhibitors (confirm specific substances with trial site).
- People who take benzodiazepine medications and who are unable to safely pause those doses for 8 hours before through to 6 hours after the study intervention.
- People who take medications that interact with psilocybin and who are unable to safely pause those doses for 8 hours before through to 6 hours after the study intervention.
- People who are currently pregnant (confirmed or suspected), or currently breastfeeding.
- People who can become pregnant and who have a positive pregnancy test at screening or before a dosing session.
- People who can become pregnant and who are unwilling or unable to use highly effective contraception from consent through to 30 days after the last dosing session.
- People who can become pregnant and who are planning to become pregnant within 30 days after the psilocybin or placebo dosing sessions.
- People who have taken part in another clinical trial within the past 30 days, or who have received another experimental drug or treatment within 30 days or within 5 half-lives of that drug (whichever is longer), where this could interfere with psilocybin.
- People who are currently receiving electroconvulsive therapy (ECT); previous ECT treatment is permitted if the last session was at least 30 days before entering the trial.
- People with a history of schizophrenia, schizoaffective disorder, psychotic symptoms, mania, or bipolar disorder.
- People who test positive on a urine drug screen (covering amphetamines, cocaine, MDMA, cannabis, opioids, ketamine, and benzodiazepines) at screening or on the morning of a dosing session.
- People who have used psychedelics (including psilocybin, LSD, DMT, 5-MeO-DMT, MDMA, or ibogaine) in the 6 months before screening.
- People with a history of Hallucinogen Use Disorder (moderate or severe), Hallucinogen Persisting Perception Disorder (HPPD), or who have ever had a negative or distressing experience with a psychedelic substance (for example, a "bad trip").
- People who currently meet the criteria for a Substance Use Disorder in the last 12 months, or who are at risk of alcohol or cannabis withdrawal — though mild alcohol or cannabis use disorder, and nicotine dependence, are not excluded (confirm with trial site).
- People who currently have a psychiatric diagnosis or mental health condition that, in the judgement of study staff, would increase risk or interfere with participation, within the six months before screening.
- People who have a history of a suicide attempt that required hospitalisation, or who have had suicidal thoughts with intent within the last 10 years.
- People who are assessed by study staff as being at high risk for suicidal behaviour during the study, based on a standardised rating scale.
- People with a neurological condition, including dementia, delirium, cognitive disorders, a history of brain or meningeal surgery, encephalitis, meningitis, degenerative brain diseases (such as Alzheimer's or Parkinson's disease), epilepsy, intellectual disability, any other condition involving significant injury to the central nervous system, or a significant head injury within the past two years.
- People with a cardiovascular (heart or blood vessel) condition, including high blood pressure, a resting heart rate that is too fast (above 90 beats per minute) or too slow (below 50 beats per minute), angina, a clinically significant abnormal heart tracing (ECG), or any other significant heart condition that the investigators determine would make participation unsafe.
- People with a significant lung or breathing condition, including a history of difficult airway management, certain physical features that suggest airway difficulties, moderate-to-severe obstructive sleep apnoea, or COPD requiring steroid treatment.
- People with clinically significant liver disease, shown by abnormal liver function test results within the past 6 months (specific values are defined in the criteria — confirm with trial site).
- People with a known allergy or sensitivity to propofol or any of its components, including eggs, soy products, or peanuts/legumes, or who have had a serious allergic reaction to any of these substances — unless they have a documented history of receiving propofol without any problems.
- People with a known allergy or sensitivity to psilocybin or its metabolites.
- People with a history of severe lipid (fat) disorders or recent pancreatitis (inflammation of the pancreas).
- People who are currently taking a GLP-1 agonist medication (such as tirzepatide), or who have taken a dose of one within the 7 days before a propofol dosing session.
- People who have symptomatic gastro-oesophageal reflux disease or other conditions that slow the stomach from emptying normally.
- People with clinically significant kidney disease, shown by kidney function tests within the past 6 months indicating reduced kidney filtration capacity (confirm specific values with trial site).
- People with an uncontrolled endocrine condition, including uncontrolled type 1 or type 2 diabetes, or a thyroid disorder diagnosed or treated (medically or surgically) within the past 6 months before screening — though well-controlled diabetes and stable thyroid hormone replacement therapy may be permitted (confirm with trial site).
- People with any other medical condition, abnormal physical exam finding, abnormal ECG result, or abnormal laboratory result that study staff determine would make participation unsafe.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
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: Dr. Boris Heifets, MD, PhD, Stanford University
Phone: 4157161585
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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 July 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Blinding Success - Correct Identification of Psilocybin at Final Dosing Session; Blinding Success - Accuracy of Guessed Psilocybin Dose at Final Dosing Session
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.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.