An interventional study of Medtronic Percept PC DBS system in Major Depressive Disorder and Treatment Resistant Depression, sponsored by Helen Mayberg, MD. Recruiting at 1 site in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Helen Mayberg, MD · Not applicable, Interventional, and Basic science
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Among 1,500 studies in Depressive Disorder, Major with a site in United States — 215 open to participants now, 259 under way, 27 of them phase 3. Depressive Disorder, Major · United States.
Among the 1,500 studies in Depressive Disorder, Major with a site in United States, this one is the 1,060th largest by planned enrollment of the 1,323 interventional ones that give a count, is one of 73 that started in 2023, is one of 472 with no phase, reaches primary completion later than 202 of the 258 other live ones, and was the 1,235th registered.
3,047 studies on the registry are indexed under Depressive Disorder, Major; 593 are open to participants now.
Browse Depressive Disorder, Major studies →215 of the 1,500 studies in Depressive Disorder, Major with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 22–60
Baylor College of Medicine · Sites in United States
Ages 18–64
Ohio State University · Sites in United States
Ages 21–65
Florida State University · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 413 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 294 (71%) stop at 75 or younger; 55 take children under 18; 99 take healthy volunteers.
This study: 25 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,500 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 135 · Phase 2 325 · Phase 3 262 · Phase 4 189
First in 1979; this study’s year is marked. 73 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 79 across 2,533 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 70 across the 1,323 interventional studies, 100 across the 171 observational. Of the 1,156 that completed or were terminated, 584 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
484 of 1,500 have an industry lead sponsor. The 10 most frequent:
Helen Mayberg, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Helen Mayberg, MD has 2 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
99 of the studies in Depressive Disorder, Major with a site in United States that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06559306Phase 3Janssen Research & Development, LLCPhase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms | 2026-12-30 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT04041479Phase 3Weill Medical College of Cornell UniversityBiomarker-guided rTMS for Treatment Resistant Depression | 2027-04 |
| NCT05850689Phase 3Intra-Cellular Therapies, Inc.Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | 2027-04-05 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Add all 99 to your calendar (.ics) → With an account.
Among the 1,500 studies in Depressive Disorder, Major with a site in United States, from their registry updates:
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Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care.
By using a DBS device called the Percept PC (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS.
The study team will recruit 20 patients with TRD and implant them with the Percept PC system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and movement, voice, and video recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open label active Deep Brain Stimulation (DBS)
Device: Medtronic Percept PC DBS system
Open label active Deep Brain Stimulation (DBS)
Change in Hamilton Depression Rating Scale (HDRS) score
Response to intervention defined as a decrease in the HDRS-17 score of 50% or greater from the 4-week average pre-surgical baseline. Clinical remission will be defined as an HDRS-17 score ≤ 7. Partial response will be defined as a decrease in HDRS-17 \>30% but less than 50%. Non-response will be defined as a \<30% decrease in HDRS-17. The score for Hamilton Depression Rating Scale, 17 item version, ranges from 0-50, with a higher score indicating more severe depression.
Time frame: baseline and up to 1 year
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS consists of 10 items evaluating core symptoms of depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0 to 6 continuum (0 = no abnormality, 6 = severe). Scores range from 0 to 60, with higher total scores indicating increased severity of depressive symptoms
Time frame: baseline and up to 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Informed consent form
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to helen.mayberg@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included in the URL field below).
Started Mar 2023 (actual). Primary completion is estimated for Dec 2028, 69 months after the start.
Of 649 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 69 months is above that.
Counting every sponsor, half of 689 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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Helen Mayberg, MD