Depression and Anxiety Trial, By Invitation NCT05487911 Sponsor: Baylor College of Medicine Condition: Depression and Anxiety
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Depression and Anxiety Trial, By Invitation

NCT05487911
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 are male or female and between 18 and 60 years old.
  • People who have been diagnosed with Major Depressive Disorder (MDD).
  • People who show depressive symptoms as measured by one of three standard questionnaires (PHQ-9, HDRS, or SHAPS).
  • People who are able to understand, agree to, and sign a consent form, and are willing to complete all study procedures.
  • Female participants who are not pregnant and not breastfeeding at the time of the brain scans and treatment sessions.
  • People who have no medical reasons preventing them from having an MRI scan (for example, no pacemaker, cochlear implants, metal in the eyes, or other metal implants), and who pass the pre-screening MRI questions from the imaging centre.
  • People who have no medical reasons preventing them from receiving TMS (a type of brain stimulation), such as no non-removable metal in the head (outside the mouth) or within 12 inches of the treatment device, and who pass the TMS safety screening questionnaire.

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, in the opinion of the clinical or research team, are unlikely to complete the study because they are not able to tolerate TMS treatment.
  • People who are unable to understand the study design and what taking part involves.
  • People who are unable to sign the consent form for any reason.
  • People who have an unstable medical condition, including HIV/AIDS, active hepatitis, active tuberculosis, unstable heart disease, unstable diabetes, or significant liver or kidney problems.
  • Female participants who are pregnant or breastfeeding.
  • People who have medical reasons preventing them from having an MRI scan (for example, a pacemaker, cochlear implants, metal in the eyes, or other metal implants), or who do not pass the imaging centre's pre-screening MRI questions.
  • People who have medical reasons preventing them from receiving TMS, such as non-removable metal in the head (outside the mouth) or within 12 inches of the treatment device, or who do not pass the TMS safety screening questionnaire; additional safety guidelines from an international expert panel on brain stimulation also apply (confirm with trial site).
  • People who do not speak English, as the study team does not currently have the resources to support other languages.

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.

GP referral letter

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Trial details

Status
By Invitation
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
4 August 2026

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.

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Functional connectivity of orbital frontal cortex (OFC); Outcome Changes in MDD subjects

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