Depression and Anxiety Trial, Recruiting NCT07507370 Sponsor: University of North Carolina, Chapel Hill Condition: Depression and Anxiety
Back to Depression And Anxiety

Depression and Anxiety Trial, Recruiting

NCT07507370
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • Adults of any gender between 18 and 70 years of age
  • People who are willing to sign a consent form and follow all study procedures for the full duration of the trial
  • People who have been diagnosed with major depressive disorder (MDD) that is not linked to psychosis, confirmed through a structured diagnostic interview
  • People whose depression symptoms score at a moderate level or higher on a standard rating scale (HDRS-17 score of 14 or above)
  • People assessed as being at low suicide risk, meaning no active suicidal thoughts in the past month and no suicide attempts, preparatory actions, or significant self-harm in the past two years
  • People who are able to understand the risks and potential benefits of joining the study
  • People of childbearing potential who have been using highly effective contraception for at least one month before screening and who agree to continue doing so during the study
  • People whose depression has not responded well to at least one antidepressant medication in the past or present, confirmed using a standardised treatment history tool (Maudsley Treatment Inventory score of 3 or above)

Who may not be able to join:

  • People diagnosed with severe alcohol use disorder in the past 12 months
  • People diagnosed with moderate to severe substance use disorder (not including tobacco) in the past 12 months
  • People with a lifetime history of bipolar disorder
  • People with a diagnosis of schizophrenia or any other psychotic disorder
  • People with a history of autism spectrum disorder (as reported by the participant)
  • People who have started a new psychiatric medication or had a dose change in the six weeks before screening
  • People who have started a new course of psychotherapy in the six weeks before screening
  • People who have received any brain stimulation treatment in the six weeks before screening
  • People with a history of seizures, other than fever-related seizures in childhood or seizures caused by electroconvulsive therapy (ECT)
  • People with neurological conditions that the investigator considers would increase risk or affect study results, such as dementia, stroke, Parkinson's disease, multiple sclerosis, significant traumatic brain injury, a ruptured brain aneurysm, or previous radiation to the brain (confirm with trial site)
  • People whose depression previously did not respond to ECT or transcranial magnetic stimulation (TMS)
  • People who have had prior brain surgery or have brain implants
  • People with a personal or family history of epilepsy
  • People with a history of fainting spells or loss of consciousness
  • People with metal in the brain, skull, or elsewhere in the body
  • People with an implanted medical device that uses electricity, or any implant in the head or neck area, or implants located within 30 centimetres of where the TMS device would be placed
  • People who are currently pregnant or breastfeeding
  • People currently enrolled in another clinical trial for depression
  • People with an unstable medical condition that the investigator believes would increase risk or prevent full participation in the study
  • 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 19 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.

Contact this trial

Principal Investigator: Flavio Frohlich, PhD, University of North Carolina, Chapel Hill

Phone: 919-966-9929

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
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
14 April 2026
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety via the presence of any serious AEs; Feasibility of the Single Session Intervention

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: 19 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