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 21 years or older.
- People who are able to lie comfortably on their back during scanning.
- People who agree to use one of the contraception methods listed in the trial's appendix.
- People who are able to give written informed consent and are willing to follow the requirements and restrictions outlined in the consent form.
- People who can read, understand, and record information written in English.
- People who have access to the internet through their own electronic device.
- People who have been diagnosed with a moderate to severe major depressive episode, according to standard psychiatric diagnostic criteria (DSM-5).
- People who score above 20 on a standard depression rating scale called the Montgomery-Åsberg Depression Rating Scale (MADRS).
- People who have never taken antidepressants, or who have not taken any antidepressant medication for at least 8 weeks before signing the consent form.
- People whose depression has not been classified as treatment-resistant.
- People who have an ongoing relationship with a GP or other healthcare professional.
- People considered to be in generally good health, as determined by a responsible doctor based on medical history, physical examination, and laboratory tests.
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 with a general medical or psychiatric condition (other than major depressive disorder, where relevant) that, in the opinion of the lead investigator, could affect their safety or the reliability of the study results.
- People currently taking medication that the investigator believes could affect participant safety or the study's scientific integrity, including medications known to interact with a specific brain receptor (serotonin 2A) or to significantly affect serotonin levels in the body.
- People who have used illicit substances in the 3 months before giving consent, including classic psychedelics, stimulants, MDMA, or cannabis.
- People who are unwilling or unable to follow the procedures set out in the study protocol.
- People who are considered mentally or legally unable to make decisions for themselves.
- People for whom blood sampling or arterial cannulation (inserting a small tube into an artery) would not be safe, such as those with peripheral vascular disease or a condition called Raynaud's phenomenon.
- People for whom the study drug dl-fenfluramine would not be safe to administer, including those taking medications that significantly affect serotonin levels.
- People with an abnormal Allen's test result (a test checking blood flow in the hand) or abnormal blood clotting results, due to the arterial procedure required for the brain scans.
- People who have taken part in another research study involving radiation exposure exceeding 10 mSv within the past year.
- People for whom MRI scans are not safe, such as those with pacemakers, certain metallic implants, metal fragments in the eye, or other concerns identified by a standard pre-MRI questionnaire.
- People who experience claustrophobia or any other condition that would prevent them from undergoing MRI or PET scanning.
- People who are pregnant or breastfeeding.
- People with a history of suicide attempts that required hospitalisation (for MDD participants).
- People with a history of another major psychiatric diagnosis (Axis I) (for MDD participants).
- People with a history of a neurological or general medical illness that, in the opinion of the investigator, could affect participant safety or the scientific integrity of the study (for MDD participants).
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: David Nutt, Professor, Centre for Psychedelic Research, Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK
Phone: +447503289090
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 in cortical [11C]Cimbi-36 non-displaceable binding potential (BPND) after dl-fenfluramine versus placebo (serotonin release capacity)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.