Deep brain stimulation for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of deep brain stimulation (DBS) targeting the subcallosal cingulate region of the brain to treat patients with treatment-resistant major depressive disorder (MDD). The Medtronic Percept PC device will be used to deliver electrical stimulation, which aims to reset the brain network associated with depressive symptoms. The study will include patients aged 25-70 who have been diagnosed with MDD and have not responded to multiple treatments. The effectiveness of this approach will be evaluated based on the patients' depressive symptoms and overall functioning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25-70 years old.
* Ability to provide written informed consent.
* Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR or DSM-5 (SCID-IV or SCID-5). Two independent psychiatrists will confirm the diagnosis, as well.
* Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.
* Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale
* Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery)
* A maximum Global Assessment of Functioning of 50 or less.
* Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as failure to respond to at least four adequate antidepressant treatments (assessed with the Antidepressant Treatment History Form \[ATHF-SF\] and verified through medical records) during the current episode. Treatments which support study inclusion include antidepressive medications, certain augmentation agents, evidenced-based psychotherapy, and neuromodulation (ECT, transcranial magnetic stimulation (TMS)). For those patients who have not received ECT, patients may be considered eligible for study participation if they have received adequate trials of an SSRI, SNRI, augmentation agent (certain atypical antipsychotic medications, Lithium), and TMS and/or ketamine.
* ability comply with study and device management procedures.

Exclusion criteria:

* Other primary Axis I conditions
* Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists
* Other primary neurological disorders or unstable medical illness
* Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
* Pregnancy or plan to come pregnant during the study
* Contraindications for general anesthesia, neurosurgery, or an MRI scan
* Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation.

Where it's running

• Icahn School of Medicine at Mount Sinai, Mount Sinai West
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Helen Mayberg, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Ellie Rapp
• Email: ellie.rapp@mssm.edu
• Phone: 646-493-1607

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• Adding ketamine to ECT for treatment-resistant depression

  This trial will test whether giving IV ketamine during ECT helps adults with treatment-resistant major depression get better faster and have fewer thinking problems.

  Recruiting Phase 3 Università Vita-Salute San Raffaele · Milan · NCT07088380

• Maintenance treatment using rTMS for depression

  This study is testing if a type of brain treatment called rTMS can help people with hard-to-treat depression stay feeling better after their initial treatment.

  Recruiting at 3 sites University of California, San Diego · San Diego, California and 2 other locations · NCT06938841

• Identifying brain biomarkers for treatment-resistant major depression using deep brain stimulation

  This study is testing if deep brain stimulation can help people with severe depression who haven't found relief from regular treatments by looking for brain signals that could predict their mood changes.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT06542094

• Using gamma oscillations to predict ketamine therapy outcomes in depression

  This study is testing if brain activity measured during ketamine treatment can help predict how well it will work for people with depression that hasn't responded to other treatments.

  Recruiting at 2 sites Phase 1 Texas A&M University · Houston, Texas and 1 other locations · NCT06480201

• Understanding the impact of mood disorders and treatment responses

  This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06462196

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.