Depression and Anxiety Trial, By Invitation NCT06512324 Sponsor: Biomedical Discoveries and Neuroscientific Foundations LLC Condition: Depression and Anxiety
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Depression and Anxiety Trial, By Invitation

NCT06512324
By Invitation Not Applicable

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 who have been diagnosed with major depressive disorder (a form of serious depression) and/or generalised anxiety disorder.
  • People who are receiving care as an outpatient (meaning they visit a clinic but do not stay overnight in hospital).
  • People who are willing and able to give their informed consent to take part in treatment.
  • People who are 12 years of age or older.
  • People who are able to attend weekly check-ins to complete the main study assessments.
  • People whose prescribing doctor has determined that a treatment called TMS (a non-invasive brain stimulation therapy) is safe and appropriate for them.
  • People who have agreed with their doctor to receive a full course of TMS treatment at one of the participating clinics.
  • People who are able to communicate in English.

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 prescribing doctor has identified a medical reason why TMS treatment would not be safe for them.
  • People whose prescribing doctor considers outpatient care unsuitable given the seriousness of their condition or other factors.
  • People who are currently having active thoughts of suicide with intent or a plan to act on those thoughts.
  • People who are unable to attend, or who do not wish to take part in, the weekly assessment schedule.
  • People who are not able to communicate in English.

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 30 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
Biomedical Discoveries and Neuroscientific Foundations LLC
Registry
ClinicalTrials.gov
Start date
27 June 2024
Est. completion
30 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]; 7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate]

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: 30 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