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 who have been diagnosed with a major depressive episode without psychotic features, based on standard psychiatric diagnostic criteria (DSM-5).
- People whose depression has not responded to at least two different antidepressant medications, each taken at an appropriate dose for at least 6 weeks.
- People whose depression scores at least 20 on a standard rating scale used to measure the severity of depression (called the MADRS).
- People who are willing and able to give written, signed consent to participate.
- People who are covered by the social security system.
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 a diagnosis of bipolar disorder.
- People who have a diagnosis of schizophrenia or any psychotic disorder.
- People with a personal or family history of psychotic disorder.
- People with a history of personality disorder.
- People with post-traumatic stress disorder, obsessive-compulsive disorder, or an eating disorder.
- People who have had an alcohol or substance use disorder in the past 12 months, or whose urine test shows the presence of certain substances at the time of assessment.
- People who have expressed certain types of suicidal thoughts in the past six months, have shown suicidal behaviour in the past six months, or are assessed as being at significant risk of suicide or self-harm during interview.
- People who have experienced a psychiatric crisis after previously using a psychedelic substance such as LSD.
- People who are pregnant or breastfeeding.
- People with a history of certain heart or blood vessel conditions, including heart attack, stroke, irregular heart rhythm, uncontrolled high blood pressure, a specific heart electrical abnormality (QT prolongation), rapid heart rate, or generally poor heart health.
- People with uncontrolled diabetes.
- People with an uncontrolled thyroid condition.
- People who have epilepsy.
- People who have Parkinson's disease and are being treated with selegiline or levodopa.
- People who have HIV and are being treated with ritonavir or indinavir.
- People with an active infection being treated with erythromycin.
- People with a fungal infection being treated with ketoconazole or itraconazole.
- People who are unable to have an MRI scan for any reason.
- People currently taking certain medications that block a specific brain receptor (5-HT2A antagonists), including quetiapine, olanzapine, or aripiprazole.
- People currently taking lithium.
- People taking certain other medications — including buprenorphine, opioids, clonidine, methyldopa, digoxin, monoamine oxidase inhibitors (MAOIs), certain enzyme inhibitors, St. John's Wort, or warfarin — unless these have been fully stopped before the study treatment begins (confirm with trial site).
- People who have received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) during their current depressive episode, or who have ever had vagus nerve stimulation, deep brain stimulation, or brain surgery for psychiatric purposes.
- People who have used psychedelic substances — such as psilocybin, LSD, ayahuasca, mescaline, or related substances — during their current depressive episode.
- People who are in custody or detained by a legal or administrative order, or who are under compulsory psychiatric care.
- People who are under legal protection or who are not able to give their own consent to participate.
- People who have any other condition that, in the opinion of the trial doctor, could affect the study results or pose a health risk to the participant.
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: Lucie BERKOVITCH, MD, GHU Paris Psychiatrie and Neurosciences - Neuromodulation Institute
Phone: +33 145657481
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 from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.