Depression and Anxiety Trial, Recruiting NCT05773755 Sponsor: Helen Mayberg, MD Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05773755
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:

  • You are between 25 and 70 years old.
  • You are able to read, understand, and sign a consent form agreeing to take part.
  • You have been diagnosed with Major Depressive Disorder (a serious form of depression) by a structured medical interview, and this has been confirmed by two separate psychiatrists.
  • Your current episode of depression has lasted at least two years, or you have had more than three separate episodes of depression in your lifetime.
  • Your depression is currently rated as severe, based on a standard depression scoring test (a score of 20 or more on a 17-item scale).
  • Your depression score has remained at or above that severe level across four weekly check-ins in the month before any surgery.
  • Your overall ability to function in daily life is significantly limited, based on a standard assessment (confirm with trial site).
  • Your depression has not responded to at least four different adequate treatments during your current episode — these may include antidepressant medications, certain add-on medications, proven talking therapies, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or ketamine.
  • You are able and willing to follow all study procedures and any requirements related to the device used in the trial.

Who may not be able to join:

  • You have another major mental health condition as your primary diagnosis.
  • You are currently having thoughts of suicide with intent to act on them, have attempted suicide in the last six months, have made more than three suicide attempts in the last two years, or are considered at serious suicide risk by the study psychiatrists.
  • You have a primary neurological condition (such as epilepsy or Parkinson's disease) or a serious unstable physical health condition.
  • You need to take blood-thinning medication that cannot be safely stopped around the time of surgery.
  • You are pregnant or planning to become pregnant during the study.
  • You have any medical reason that would make it unsafe for you to have general anaesthesia, brain surgery, or an MRI scan.
  • You already have a fitted cardiac pacemaker, defibrillator, or any other implanted electrical device that could interfere with the device used in this trial.

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 June 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

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

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Helen Mayberg, MD
Registry
ClinicalTrials.gov
Start date
1 March 2023
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Hamilton Depression Rating Scale (HDRS) score

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 June 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