Phase 2 Depression and Anxiety Trial, Not Yet Recruiting NCT07499583 Sponsor: Indiana University Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Not Yet Recruiting

NCT07499583
Not Yet Recruiting Phase 2

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

  • The person must be a veteran or a first responder (such as a paramedic, firefighter, or police officer).
  • The person must be between 18 and 70 years of age.
  • The person must have treatment-resistant depression — meaning they are currently experiencing a major depressive episode without psychotic features, and at least two different antidepressant medications have not worked during this current episode (as confirmed using a standard diagnostic interview).
  • The person must have moderate to severe problems with one main substance, which must be alcohol, cocaine, opioids/heroin, or cannabis; moderate to severe use of nicotine alongside this is also acceptable, as is mild or recreational use of other substances.
  • The person must be able to read English and complete study questionnaires and consent forms.
  • The person must be in good general health, as confirmed through a screening check-up and medical history review.
  • The person must be able to safely have an MRI scan.

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 certain psychiatric conditions are not eligible, including schizophrenia, schizoaffective disorder, bipolar disorder, current post-traumatic stress disorder, or a history of a medically serious suicide attempt.
  • People who are actively or imminently at risk of suicide, as measured by specific scores on standard depression and suicide rating scales, are not eligible.
  • People with a family history of schizophrenia or schizoaffective disorder in a first- or second-degree relative, or bipolar disorder type 1 in a first-degree relative, are not eligible.
  • People taking SSRIs (a type of antidepressant) or certain other medications may not be eligible unless the dose has been stable for at least 6 months and the medication is not considered unsafe to combine with psilocybin, as determined by the study physician, Dr Conroy (confirm with trial site).
  • People who have ever used classic psychedelics before, including psilocybin, are not eligible.
  • People with certain medical conditions that could make participation unsafe are not eligible — examples include seizure disorders, severely reduced liver function, heart disease, heart failure, history of stroke, severe asthma, an overactive thyroid, narrow-angle glaucoma, or certain urinary or digestive tract conditions.
  • People with a resting blood pressure below 90/50 mmHg or above 165/95 mmHg are not eligible.
  • People with certain heart rhythm abnormalities shown on an ECG, including a QT interval measurement above a specific threshold, are not eligible.
  • People who are pregnant or breastfeeding are not eligible.

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 7 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
  • 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: Susan K Conroy, PhD, Indiana University

Phone: 317-948-5450

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
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 January 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

percentage number of participants with Adverse Events (AEs); Change in % number of positive urines; Change in % number of days spent using substances; Change in severity of depression symptoms; Changes in plasma brain-derived neurotrophic factor (BDNF) during stress exposure; Change in resting brain functional connectivity of the default mode network (DMN).

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: 7 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