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 diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and/or schizophrenia.
- People with bipolar disorder who meet the formal diagnostic criteria for BD (any subtype), have a symptom severity score above 40 on a standard rating scale called the BPRS, and whose condition is not considered mild.
- People with major depressive disorder whose symptoms score above 10 on a standard questionnaire called the PHQ-9, and whose condition is not considered mild.
- People with schizophrenia who meet the formal diagnostic criteria for schizophrenia (any subtype), have a BPRS score above 40, and whose condition is not considered mild.
- People who have not been hospitalised for their mental health condition in the past 3 months (applies to all three diagnoses above).
- People who are currently on a stable and appropriate dose of an antidepressant (such as an SSRI) or other psychiatric medication, provided the dose has been consistent; certain sleep medications (such as zolpidem, zaleplon, melatonin, or trazodone) are also permitted if the dose has been stable for at least four weeks before screening and is expected to stay the same.
- People who are willing and able to give informed consent to take part, in English.
- People who live within the United States.
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 followed a ketogenic diet or were in a state of ketosis within the 3 months before wanting to enrol.
- People who are pregnant or breastfeeding.
- People who depend on insulin.
- People who have a developmental delay alongside their primary diagnosis.
- People who are currently experiencing a severe mood episode or psychotic state that would make it difficult to attend study visits or follow dietary programs.
- People who have been hospitalised or have taken the medication clozapine at doses above 550mg in the past 3 months.
- People who are unable to complete the initial baseline measurements required by the study.
- People with severe kidney or liver problems.
- People with certain heart conditions, including congestive heart failure, angina, irregular heartbeat (arrhythmias), cardiomyopathy, or valvular heart disease.
- People who are actively misusing alcohol or illicit drugs, or who currently have a diagnosis of a Substance Use Disorder (as defined by standard diagnostic criteria), with the exception of nicotine or cannabis dependence.
- People who are actively suicidal and considered to be at significant risk of suicide during the course of the study.
- People who are currently taking part in, or have taken part in within the past month, another clinical trial involving an investigational drug, device, or intervention that might interfere with this study.
- People whose symptoms are rated as mild on the BPRS scale at the screening or baseline visits.
- People with a history of traumatic brain injury (TBI).
- People with any other medical condition that the study medical team considers would make a dietary intervention unsafe (for example, anorexia nervosa), or where the study team determines there is insufficient ability to control food intake to follow the study diets.
- People with any medical condition that the study doctors or lead researcher believe would interfere with taking part in or evaluating the results of the study.
- People with a personal or family history of familial hypercholesterolaemia (an inherited condition affecting cholesterol levels).
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: Shebani Sethi, MD, ABOM, Stanford University
Phone: (650) 725-0169
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
WHO-5 Well-being Index; Functioning Assessment Short Test (FAST); Quality of Life Scale (QIDS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.