Phase 3 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 between 18 and 65 years of age (any gender) may be considered.
- People who have been diagnosed with Major Depressive Disorder (MDD) as their main condition, based on standard diagnostic guidelines, whether it is a first or repeated episode — with the current episode lasting at least 3 months for first-time patients, or at least 1 month for those who have had previous episodes.
- People whose depression is rated as moderately severe or worse on standard clinical rating scales at both the screening and baseline assessments (confirm with trial site for specific score thresholds).
- People who are able to read and understand the trial requirements, are willing to follow the study rules, attend scheduled visits, and have signed a consent form before joining.
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 scores improved by 25% or more between the initial screening and the start of the trial.
- People who have a clinically significant risk of suicide, self-harm, or harming others — including those who score highly on a suicide-related rating scale, those judged by the doctor to be at significant suicide risk based on recent thoughts or plans, or those who have attempted suicide during their current depressive episode.
- People who also meet the diagnostic criteria for other mental health conditions, such as schizophrenia, bipolar disorder, anxiety disorders, obsessive-compulsive disorders, somatic symptom disorders, or substance use and addiction disorders.
- People whose depression falls into certain specific categories — including those whose depression has not responded to two or more antidepressants tried at full doses for at least 8 weeks each (treatment-resistant depression), those whose depression is caused by another medical condition such as an underactive thyroid, or those whose depression is caused by substances or medications.
- People who have taken certain interacting medications within a period shorter than 5 half-lives before joining the trial — including strong inhibitors or inducers of certain liver enzymes (such as fluoxetine, rifampicin, or carbamazepine), medications known to affect heart rhythm in a specific way, or antipsychotics, antidepressants, or mood stabilisers (confirm with trial site for specific timing).
- People who have previously tried a full course (at least 8 weeks) of sertraline at the maximum recommended dose without success, or who have a known allergy to sertraline.
- People who stopped taking a class of medications called MAOIs (such as phenelzine or linezolid) less than 2 weeks before joining the trial.
- People currently taking long-acting antipsychotic medications.
- People who have received certain non-medication treatments within 3 months before screening — including electroconvulsive therapy (ECT), structured psychotherapy (such as cognitive behavioural therapy), transcranial magnetic stimulation (TMS), vagus nerve stimulation, or light therapy — or those who the doctor believes currently need any of these treatments.
- People who have taken part in another clinical trial within the 3 months before screening.
- People with certain heart rhythm problems detected on an ECG, including second- or third-degree heart block, long QT syndrome, or a QTc measurement above a certain level, or those otherwise judged unsuitable by the doctor due to heart rhythm issues.
- People with significantly abnormal liver enzyme levels on blood tests, severely abnormal thyroid function, or abnormalities across two or more thyroid function markers.
- People who have a history of allergic reactions to multiple medications, or who are allergic to a class of antidepressants called SNRIs.
- People with a history of seizures, or any condition that may increase the risk of seizures, such as stroke, serious head injury, or significant metabolic disorders.
- People with a clinically significant or unstable ongoing condition affecting the blood, hormones, heart, lungs, kidneys, liver, digestive system, infections, or nervous system, as judged by the doctor.
- People with a history of cancer — including blood cancers, solid tumours, or carcinoma in situ — within the past 5 years (with some exceptions for certain fully treated skin cancers or cervical carcinoma in situ, confirm with trial site).
- People with a history of raised eye pressure or a type of glaucoma called narrow-angle glaucoma.
- People with conditions that may prevent oral medications from being properly absorbed, such as active bowel disease, intestinal blockage, or chronic diarrhoea.
- Women who are breastfeeding or who test positive for pregnancy during screening or during the study.
- People who have been dependent on alcohol or drugs in the 3 months before screening.
- Men or women of childbearing potential who are not willing to use effective contraception throughout the study and for 1 month after the trial ends.
- People who, in the opinion of the doctor, have any other reason that makes participation in the trial unsuitable.
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: 86-0311-69085587
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.