Deep brain stimulation for treatment-resistant depression
Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Percept PC System
This study is testing if deep brain stimulation can help people aged 25-70 with severe depression who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05773755 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-70 with a diagnosis of major depressive disorder who have experienced treatment-resistant depression.
Not a fit: Patients with major depressive disorder who do not meet the criteria for treatment resistance or those with psychotic features may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from severe depression who have not responded to conventional therapies.
How similar studies have performed: Previous studies using deep brain stimulation for treatment-resistant depression have shown promising results, with sustained antidepressant effects in a significant percentage of patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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: Isha Trivedi
- Email: isha.trivedi@mssm.edu
- Phone: 212-523-8242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.