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
- Adults aged 18 to 65 years.
- People who are able and willing to sign a written consent form agreeing to take part.
- People who have been diagnosed with schizophrenia, bipolar disorder, or major depressive disorder according to recognised diagnostic standards, confirmed through a structured interview tool called the M.I.N.I.
- Female participants who could become pregnant must agree to use an effective form of contraception during the trial.
- People whose mental health symptoms are considered stable, based on specific symptom rating scale scores, and who have been on a stable psychiatric medication regimen for at least 2 weeks.
- People who have reduced day-to-day functioning at the time of screening, based on a specific quality-of-life score (SF-36 score of 40 or below).
- People who take benzodiazepines (a type of calming or sleep medication) only if their daily dose is at or below a low threshold amount (2 mg lorazepam equivalent per day).
- People whose general physical health has been stable for at least 4 weeks.
- For the semaglutide (weight management medication) part of the trial: people who are overweight with a BMI of at least 27 and below 30, plus at least one weight-related health condition, or people with obesity with a BMI of 30 or above.
- For an optional brain stimulation component: people with a depression symptom score at or above a certain level on the MADRS rating scale (score of 19 or higher).
- People who the trial investigator believes will be able to follow the study procedures as required.
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 are unable to give informed consent to participate.
- People who have a current or past neurological condition or a structural brain abnormality that could affect how the study is conducted.
- People with a known allergy or intolerance to semaglutide (the study medication).
- People who are currently pregnant or breastfeeding.
- People who are assessed as having a serious risk of suicide.
- People who have had a problem with substance dependence (such as alcohol or drugs) within the last 3 months.
- People with a BMI below 18.5 kg/m² (considered underweight).
- People with significantly reduced kidney function, based on a kidney filtering test result below a certain level (eGFR less than 30 mL/min/1.73 m²).
- People with type 1 diabetes, a serious diabetes complication called diabetic ketoacidosis, diabetes-related eye disease (diabetic retinopathy), or poorly controlled diabetes with repeated episodes of low blood sugar.
- People with pancreatitis (inflammation of the pancreas), a history of pancreatitis, or pancreatic cancer.
- People with a condition called multiple endocrine neoplasia type 2, or a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer).
- People with significant pre-existing digestive conditions such as inflammatory bowel disease or a condition where the stomach empties too slowly (gastroparesis).
- People who need urgent surgery.
- People with another medical condition that could affect the study procedures or their safety during the trial.
- For the optional brain stimulation component: people with non-removable metal in or around the head, known raised pressure in the skull due to stroke or injury, a history of working with metal professionally or a previous eye injury from metal, a history of a brain stimulation treatment called rTMS or ECT, or people currently receiving a medication called (es)ketamine.
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
Phone: +49 89 4400 - 55501
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 Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
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.