Phase 2 Depression and Anxiety Trial, Not Yet Recruiting NCT07247370 Sponsor: South West Sydney Local Health District Condition: Depression and Anxiety
Back to Depression And Anxiety

Phase 2 Depression and Anxiety Trial, Not Yet Recruiting

NCT07247370
Not Yet Recruiting Phase 2 🇦🇺 Australian site

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

  • You have been diagnosed with moderate to severe alcohol use disorder (AUD) based on standard psychiatric guidelines (DSM-5)
  • You currently have a diagnosis of Major Depressive Disorder (MDD) based on standard psychiatric guidelines (DSM-5)
  • You are motivated to cut down or stop drinking alcohol
  • In the month before screening, you drank at least 21 standard drinks per week, or had at least 2 days per week where you drank heavily (5 or more drinks in a day for men; 4 or more for women)
  • You are between 18 and 70 years old
  • You have sufficient thinking and English language skills to understand and consent to the study and take part in interviews
  • You have a stable place to live
  • You are willing to sign a consent form agreeing to take part
  • You are willing to follow the study procedures and attend all required appointments

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.

  • You have been diagnosed, now or in the past, with a psychotic disorder, bipolar I disorder, or a psychosis caused by substance use
  • You are currently at high risk of suicide, or have made a suicide attempt in the past 6 months
  • You have been diagnosed, now or in the past, with moderate to severe misuse of ketamine or similar dissociative drugs
  • You have used ketamine (whether prescribed or not) in the past 4 weeks
  • You are already taking part in another clinical trial that could affect your safety or the results of this study
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have serious uncontrolled health conditions, such as poorly controlled high blood pressure, severe heart disease, a history of stroke or brain injury, or severe liver, bladder, or kidney disease (confirm with trial site)
  • You are showing significant signs of alcohol withdrawal at the time of screening
  • You have a history of raised pressure in the brain, seizures, or an epilepsy diagnosis (except for fever-related seizures in childhood)
  • You have a known allergy or sensitivity to ketamine or its ingredients
  • You are currently taking psychiatric medications, unless you have been on a stable dose of antidepressants for at least 4 weeks
  • You have a current moderate or severe addiction to substances other than nicotine or caffeine (although stable opioid use disorder on maintenance treatment may be permitted — confirm with trial site)
  • The study doctor decides that, for any reason, taking part would not be safe for you or could affect the study results

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026

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
  • Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
  • headspace — mental health support for 12 to 25 year olds: headspace.org.au
  • 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: +61295153636

Australian sites

Drug Health Services, Royal Prince Alfred Hospital, Sydney, New South Wales

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

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
South West Sydney Local Health District
Registry
ClinicalTrials.gov
Start date
10 December 2025
Est. completion
10 April 2027

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Feasibility will be assessed through recruitment rates, retention to follow-up, session attendance, and treatment adherence.; Safety will be assessed through the frequency, severity, and relatedness of adverse events (AEs), including dissociation, affective destabilisation, and vital sign abnormalities.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov