Phase 2 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 between 21 and 60 years old.
- People who are fluent in English.
- People who are able to swallow capsules.
- People who are currently experiencing a major depressive episode, or who have a history of major depressive episodes, as defined by standard diagnostic guidelines (DSM-5).
- People who currently have active depressive symptoms, measured by a score above 16 on a standard depression rating scale covering the past two weeks.
- People who have an identified support person — a trusted adult friend or relative — who is able to pick them up from the UCLA Semel Institute and drive them home after study sessions involving the study drug.
- Women who could become pregnant must be using one highly effective form of contraception (such as the oral contraceptive pill), must be willing to continue using it for the full duration of the study, and must be willing to take on-site pregnancy tests.
- People who agree not to use any substance that affects the mind — including alcohol — within 24 hours before each drug session and during the sessions (usual amounts of caffeine before and after sessions are permitted).
- People who agree not to take any as-needed ("PRN") medications on the mornings of the drug sessions.
- People who have been medically cleared to participate by a physician.
- People who have previously been prescribed blood pressure medication must continue taking it throughout the study.
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 personally have, or whose immediate family members have, a history of psychosis or mania.
- People whose resting blood pressure is above 140 (systolic) or 90 (diastolic), or whose resting heart rate is above 90 beats per minute, based on an average of four separate measurements.
- People who meet the diagnostic criteria for a DSM-5 Cluster B personality disorder, which includes narcissistic, histrionic, borderline, or antisocial personality disorder.
- People who are currently at risk of suicide (based on a specific score on a standard rating scale) or who have another psychiatric condition that requires immediate treatment.
- People who are currently taking antidepressants, other substances that affect serotonin levels (such as St. John's Wort or 5-HTP), lithium, or the medication efavirenz — regardless of what condition these are prescribed for.
- People who are currently taking opioid medications, such as codeine, fentanyl, hydrocodone, meperidine, or tramadol.
- People who are currently receiving cognitive behavioural therapy (CBT).
- People who have any of the following heart or cardiovascular conditions: uncontrolled high blood pressure, coronary artery disease, congenital long QT syndrome, an enlarged heart, reduced blood flow to the heart, heart failure, a previous heart attack, a consistently fast heart rate, an artificial heart valve, a significant abnormality on a screening heart tracing (ECG), or any other significant cardiovascular condition.
- People whose heart rhythm measurement (QTc interval) on a baseline ECG is above 450 milliseconds (for males) or above 460 milliseconds (for females).
- People who have a history of stroke or a transient ischaemic attack (sometimes called a "mini-stroke").
- People who have epilepsy or a history of seizures.
- People who have insulin-dependent diabetes.
- People who meet the criteria for a substance use or dependence disorder within the past six months, including for nicotine or cannabis.
- People who test positive for illicit substances on a urine drug screen (not including cannabis).
- People who have used psychedelics or ketamine within the past 12 months.
- People who have previously had a bad or harmful reaction to a psychedelic substance that works on the 5-HT2A receptor (confirm with trial site).
- People who are pregnant, trying to become pregnant, or currently breastfeeding.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Treatment acceptability; Feasibility as measured by participant retention; Hamilton Depression Rating Scale
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.