Phase 2 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
- The trial is open to people assigned either female or male at birth.
- Participants must be between 21 and 65 years old at the time of screening.
- Participants must have a body mass index (BMI) between 18 and 30 at the time of screening.
- Participants must weigh at least 60 kg.
- Participants must have a diagnosis of major depressive disorder (MDD), confirmed through a structured clinical interview.
- Depression must be rated as moderate to severe based on a specific clinical scoring tool (MADRS score of 21 or higher).
- Anxiety must be rated as moderate to severe based on a specific clinical scoring tool (GAD-7 score of 10 or higher).
- Participants must have had an inadequate response to their current antidepressant medication during their current episode of depression.
- Participants must have been taking a stable dose of an antidepressant (SSRI or SNRI type) for at least one month before screening, with no more than a 50% change in dose during that time.
- Participants who are capable of producing sperm must agree to use a condom throughout the trial and for 3 months after receiving the trial medication if their partner could become pregnant. Their partner must also use a highly effective form of contraception during this period.
- Participants who could become pregnant must agree to use a highly effective form of contraception, along with their partner using a condom, throughout the trial and for 3 months after dosing, and must have a negative pregnancy test at screening and at the start of the study.
- Participants who cannot become pregnant but were previously capable of producing eggs must either be postmenopausal (no periods for at least 12 months, with hormone levels confirmed by a blood test) or have had a surgical procedure such as a hysterectomy, removal of both fallopian tubes, or removal of both ovaries (confirm with trial site regarding hormone replacement therapy or hormonal contraception use).
- Participants must be willing and able to provide written informed consent and follow all study requirements.
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 whose depression score improves by 25% or more between the screening visit and the baseline visit.
- People who have not responded to more than two antidepressant treatments given at appropriate doses for an appropriate length of time during their current episode of depression.
- People who have a current or past diagnosis of schizophrenia or related psychotic disorders, bipolar disorder, or a current personality disorder (as identified through a clinical interview).
- People assessed as having a clinically significant risk of suicide, including those who score 4 or higher on a specific suicidal thinking scale (C-SSRS) in the past 6 months, or who have any history of suicidal behaviour.
- People with a history of substance use disorder in the past 12 months, those who drink more than 21 units of alcohol per week, or those who are unable to avoid alcohol for 48 hours before screening and each scheduled study visit.
- People currently taking certain types of antidepressants or psychiatric medications, including monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, antipsychotics, mood stabilisers, or other antidepressants that are not SSRIs or SNRIs (such as bupropion or mirtazapine).
- People who have used psychedelic substances (such as psilocybin, LSD, ayahuasca, mescaline, or peyote) more than 10 times in the past 10 years, or any psychedelic use within 6 months before screening.
- People who have taken certain medications or supplements that could interact with the study drug in the 28 days before dosing (stable antidepressants and certain sleep aids may be allowed — the trial team would review each case individually).
- People with a family history of schizophrenia or schizoaffective disorder in a parent or sibling, or a family history of bipolar disorder type 1 in a parent or sibling.
- People with a significant history of physical health conditions that could interfere with the study, including neurological, heart, lung, digestive, liver, kidney, or hormonal conditions, as assessed by the trial doctor.
- People with a history of brain-related conditions such as epilepsy, seizures, increased pressure in the skull, brain bleeds, aneurysms, or brain tumours.
- People with a diagnosis of high blood pressure or irregular heart rhythm.
- People with a significantly abnormal resting heart rate (above 100 beats per minute) or blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg) at screening.
- People with clinically significant abnormalities on a heart tracing (ECG) at the screening visit.
- People whose corrected heart interval measurement (QTcF) on an ECG is above 450 milliseconds at screening.
- People with an underactive thyroid or abnormal thyroid function test results (a repeat test may be allowed — confirm with trial site).
- People with clinically significant abnormal results from blood tests, urine tests, ECG, or physical examination at screening (a repeat test may be allowed in some cases — confirm with trial site).
- People whose personal circumstances, behaviour, or current situation the trial doctor determines could interfere with safe or effective participation.
- People with a medical or surgical history that may affect how the body absorbs, processes, or removes the study drug.
- People with any other condition or concurrent treatment that, in the trial doctor's opinion, would pose an unacceptable risk or interfere with the study.
- People who are not fluent in English.
- People with elevated liver-related blood test results (AST, ALT, GGT, or total bilirubin at 1.5 times or more above the normal upper limit) at screening (a repeat test may be allowed at the investigator's discretion).
- People who test positive for drugs of abuse or alcohol at screening or at the start of the study (a positive result for cannabis at screening may not automatically exclude someone — the trial team would assess this individually, and a negative test would be required on the day of dosing).
- People who consume excessive amounts of caffeine or related substances such as chocolate, coffee, tea, or caffeinated drinks, as determined by the trial doctor.
- People who have taken part in another clinical trial and received a study medication or experimental substance within 3 months before the dosing date for this study.
- People with a known sensitivity to psilocin or any ingredients in the study drug formulation, or who have fructose intolerance or malabsorption (as the drink used to deliver the study drug contains fructose).
- People who are currently taking, or have taken within the past 28 days, any medication known to inhibit monoamine oxidase.
- People who are currently taking, or have taken within the past 28 days, over-the-counter doses of 5-hydroxytryptophan (5-HTP) or St John's Wort.
- People who have done strenuous exercise within 48 hours before any visit or while at the study site.
- Participants capable of producing sperm who are unwilling to avoid sperm donation from the first dose until 3 months after the final dose.
- Participants who could become pregnant and are currently pregnant, breastfeeding, or planning to become pregnant.
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: Luan Phan, MD, Ohio State University
Phone: 6142935517
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
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of CYB003 in participants with MDD and anxiety; Changes in region-to-region connectivity measured by fMRI after one dose of CYB003 in patients with depression and anxiety; Changes in event related potentials (ERP) after one dose of CYB003 in participants with MDD and anxiety; Changes in acoustic startle electromyographic (EMG) response after one dose of CYB003 in patients with depression and anxiety
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.