Major Depressive DisorderNCT05773755
DBS for TRD With the Medtronic Percept PC
A study testing Medtronic Percept PC DBS system in people with Major Depressive Disorder and Treatment Resistant Depression, run by Helen Mayberg, MD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- Medtronic Percept PC DBS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai, Mount Sinai West
New York, New York, 10019
About this study
Official title: Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Percept PC System
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.
- Being tested
- Medtronic Percept PC DBS system
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Percept PC DBS systemDevice
Open label active Deep Brain Stimulation (DBS)
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation (DBS) for Treatment Resistant Depression | Experimental | Open label active Deep Brain Stimulation (DBS) Receives: Device: Medtronic Percept PC DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and up to 1 year
Secondary outcomes (1)
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
Measured: baseline and up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Mar 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be implanted with the study device and receive open label, active DBS stimulation
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen Mayberg, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Sponsor-investigator, Helen Mayberg, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Helen Mayberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773755
- Sponsor's protocol ID
- STUDY-22-01731
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Riva-Posse P, Choi KS, Holtzheimer PE, Crowell AL, Garlow SJ, Rajendra JK, McIntyre CC, Gross RE, Mayberg HS. A connectomic approach for subcallosal cingulate deep brain stimulation surgery: prospective targeting in treatment-resistant depression. Mol Psychiatry. 2018 Apr;23(4):843-849. doi: 10.1038/mp.2017.59. Epub 2017 Apr 11.
PubMed 28397839Crowell AL, Riva-Posse P, Holtzheimer PE, Garlow SJ, Kelley ME, Gross RE, Denison L, Quinn S, Mayberg HS. Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression. Am J Psychiatry. 2019 Nov 1;176(11):949-956. doi: 10.1176/appi.ajp.2019.18121427. Epub 2019 Oct 4.
PubMed 31581800Riva-Posse P, Crowell AL, Wright K, Waters AC, Choi K, Garlow SJ, Holtzheimer PE, Gross RE, Mayberg HS. Rapid Antidepressant Effects of Deep Brain Stimulation and Their Relation to Surgical Protocol. Biol Psychiatry. 2020 Oct 15;88(8):e37-e39. doi: 10.1016/j.biopsych.2020.03.017. Epub 2020 May 14. No abstract available.
PubMed 32418613Smart O, Choi KS, Riva-Posse P, Tiruvadi V, Rajendra J, Waters AC, Crowell AL, Edwards J, Gross RE, Mayberg HS. Initial Unilateral Exposure to Deep Brain Stimulation in Treatment-Resistant Depression Patients Alters Spectral Power in the Subcallosal Cingulate. Front Comput Neurosci. 2018 Jun 12;12:43. doi: 10.3389/fncom.2018.00043. eCollection 2018.
PubMed 29950982Waters AC, Veerakumar A, Choi KS, Howell B, Tiruvadi V, Bijanki KR, Crowell A, Riva-Posse P, Mayberg HS. Test-retest reliability of a stimulation-locked evoked response to deep brain stimulation in subcallosal cingulate for treatment resistant depression. Hum Brain Mapp. 2018 Dec;39(12):4844-4856. doi: 10.1002/hbm.24327. Epub 2018 Aug 18.
PubMed 30120851Veerakumar A, Tiruvadi V, Howell B, Waters AC, Crowell AL, Voytek B, Riva-Posse P, Denison L, Rajendra JK, Edwards JA, Bijanki KR, Choi KS, Mayberg HS. Field potential 1/f activity in the subcallosal cingulate region as a candidate signal for monitoring deep brain stimulation for treatment-resistant depression. J Neurophysiol. 2019 Sep 1;122(3):1023-1035. doi: 10.1152/jn.00875.2018. Epub 2019 Jul 17.
PubMed 31314668Howell B, Choi KS, Gunalan K, Rajendra J, Mayberg HS, McIntyre CC. Quantifying the axonal pathways directly stimulated in therapeutic subcallosal cingulate deep brain stimulation. Hum Brain Mapp. 2019 Feb 15;40(3):889-903. doi: 10.1002/hbm.24419. Epub 2018 Oct 11.
PubMed 30311317Smith EE, Choi KS, Veerakumar A, Obatusin M, Howell B, Smith AH, Tiruvadi V, Crowell AL, Riva-Posse P, Alagapan S, Rozell CJ, Mayberg HS, Waters AC. Time-frequency signatures evoked by single-pulse deep brain stimulation to the subcallosal cingulate. Front Hum Neurosci. 2022 Aug 18;16:939258. doi: 10.3389/fnhum.2022.939258. eCollection 2022.
PubMed 36061500Tiruvadi V, James S, Howell B, Obatusin M, Crowell A, Riva-Posse P, Gross RE, McIntyre CC, Mayberg HS, Butera R. Mitigating Mismatch Compression in Differential Local Field Potentials. IEEE Trans Neural Syst Rehabil Eng. 2023;31:68-77. doi: 10.1109/TNSRE.2022.3217469. Epub 2023 Jan 30.
PubMed 36288215Tiruvadi V, Choi KS, Gross RE, Butera R, Jirsa V, Mayberg H. Dynamic Oscillations Evoked by Subcallosal Cingulate Deep Brain Stimulation. Front Neurosci. 2022 Feb 23;16:768355. doi: 10.3389/fnins.2022.768355. eCollection 2022.
PubMed 35281513Harati S, Crowell A, Mayberg H, Nemati S. Depression Severity Classification from Speech Emotion. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5763-5766. doi: 10.1109/EMBC.2018.8513610.
PubMed 30441645Harati S, Crowell A, Huang Y, Mayberg H, Nemati S. Classifying Depression Severity in Recovery From Major Depressive Disorder via Dynamic Facial Features. IEEE J Biomed Health Inform. 2020 Mar;24(3):815-824. doi: 10.1109/JBHI.2019.2930604. Epub 2019 Jul 23.
PubMed 31352356Harati S, Crowell A, Mayberg H, Nemati S. Addressing the Credit Assignment Problem in Treatment Outcome Prediction using Temporal Difference Learning. Pac Symp Biocomput. 2020;25:43-54.
PubMed 31797585Mazza A, Barucchi AM, Solimei GE, Viti M. [Clinical and immunological aspects of Lichen ruber planus]. Arch Stomatol (Napoli). 1988 Oct;29(4):657-66. Italian.
PubMed 3274606Riva-Posse P, Holtzheimer PE, Garlow SJ, Mayberg HS. Practical considerations in the development and refinement of subcallosal cingulate white matter deep brain stimulation for treatment-resistant depression. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e25-34. doi: 10.1016/j.wneu.2012.11.074. Epub 2012 Dec 13.
PubMed 23246630
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Percept PC System
- ClinicalTrials.gov ID
- NCT05773755
- Acronym / sponsor ID
- STUDY-22-01731
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Helen Mayberg, MDUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be implanted with the study device and receive open label, active DBS stimulation
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation (DBS) for Treatment Resistant Depression | Experimental | Device: Medtronic Percept PC DBS systemOpen label active Deep Brain Stimulation (DBS) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Percept PC DBS systemOpen label active Deep Brain Stimulation (DBS) | Device | Deep Brain Stimulation (DBS) for Treatment Resistant Depression |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS) score
Time frame: baseline and up to 1 year
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.
1 secondary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: baseline and up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 28397839Riva-Posse P, Choi KS, Holtzheimer PE, Crowell AL, Garlow SJ, Rajendra JK, McIntyre CC, Gross RE, Mayberg HS. A connectomic approach for subcallosal cingulate deep brain stimulation surgery: prospective targeting in treatment-resistant depression. Mol Psychiatry. 2018 Apr;23(4):843-849. doi: 10.1038/mp.2017.59. Epub 2017 Apr 11.
- Background: PubMed 31581800Crowell AL, Riva-Posse P, Holtzheimer PE, Garlow SJ, Kelley ME, Gross RE, Denison L, Quinn S, Mayberg HS. Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression. Am J Psychiatry. 2019 Nov 1;176(11):949-956. doi: 10.1176/appi.ajp.2019.18121427. Epub 2019 Oct 4.
- Background: PubMed 32418613Riva-Posse P, Crowell AL, Wright K, Waters AC, Choi K, Garlow SJ, Holtzheimer PE, Gross RE, Mayberg HS. Rapid Antidepressant Effects of Deep Brain Stimulation and Their Relation to Surgical Protocol. Biol Psychiatry. 2020 Oct 15;88(8):e37-e39. doi: 10.1016/j.biopsych.2020.03.017. Epub 2020 May 14. No abstract available.
- Background: PubMed 29950982Smart O, Choi KS, Riva-Posse P, Tiruvadi V, Rajendra J, Waters AC, Crowell AL, Edwards J, Gross RE, Mayberg HS. Initial Unilateral Exposure to Deep Brain Stimulation in Treatment-Resistant Depression Patients Alters Spectral Power in the Subcallosal Cingulate. Front Comput Neurosci. 2018 Jun 12;12:43. doi: 10.3389/fncom.2018.00043. eCollection 2018.
- Background: PubMed 30120851Waters AC, Veerakumar A, Choi KS, Howell B, Tiruvadi V, Bijanki KR, Crowell A, Riva-Posse P, Mayberg HS. Test-retest reliability of a stimulation-locked evoked response to deep brain stimulation in subcallosal cingulate for treatment resistant depression. Hum Brain Mapp. 2018 Dec;39(12):4844-4856. doi: 10.1002/hbm.24327. Epub 2018 Aug 18.
- Background: PubMed 31314668Veerakumar A, Tiruvadi V, Howell B, Waters AC, Crowell AL, Voytek B, Riva-Posse P, Denison L, Rajendra JK, Edwards JA, Bijanki KR, Choi KS, Mayberg HS. Field potential 1/f activity in the subcallosal cingulate region as a candidate signal for monitoring deep brain stimulation for treatment-resistant depression. J Neurophysiol. 2019 Sep 1;122(3):1023-1035. doi: 10.1152/jn.00875.2018. Epub 2019 Jul 17.
- Background: PubMed 30311317Howell B, Choi KS, Gunalan K, Rajendra J, Mayberg HS, McIntyre CC. Quantifying the axonal pathways directly stimulated in therapeutic subcallosal cingulate deep brain stimulation. Hum Brain Mapp. 2019 Feb 15;40(3):889-903. doi: 10.1002/hbm.24419. Epub 2018 Oct 11.
- Background: PubMed 36061500Smith EE, Choi KS, Veerakumar A, Obatusin M, Howell B, Smith AH, Tiruvadi V, Crowell AL, Riva-Posse P, Alagapan S, Rozell CJ, Mayberg HS, Waters AC. Time-frequency signatures evoked by single-pulse deep brain stimulation to the subcallosal cingulate. Front Hum Neurosci. 2022 Aug 18;16:939258. doi: 10.3389/fnhum.2022.939258. eCollection 2022.
- Background: PubMed 36288215Tiruvadi V, James S, Howell B, Obatusin M, Crowell A, Riva-Posse P, Gross RE, McIntyre CC, Mayberg HS, Butera R. Mitigating Mismatch Compression in Differential Local Field Potentials. IEEE Trans Neural Syst Rehabil Eng. 2023;31:68-77. doi: 10.1109/TNSRE.2022.3217469. Epub 2023 Jan 30.
- Background: PubMed 35281513Tiruvadi V, Choi KS, Gross RE, Butera R, Jirsa V, Mayberg H. Dynamic Oscillations Evoked by Subcallosal Cingulate Deep Brain Stimulation. Front Neurosci. 2022 Feb 23;16:768355. doi: 10.3389/fnins.2022.768355. eCollection 2022.
- Background: PubMed 30441645Harati S, Crowell A, Mayberg H, Nemati S. Depression Severity Classification from Speech Emotion. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5763-5766. doi: 10.1109/EMBC.2018.8513610.
- Background: PubMed 31352356Harati S, Crowell A, Huang Y, Mayberg H, Nemati S. Classifying Depression Severity in Recovery From Major Depressive Disorder via Dynamic Facial Features. IEEE J Biomed Health Inform. 2020 Mar;24(3):815-824. doi: 10.1109/JBHI.2019.2930604. Epub 2019 Jul 23.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Mayberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Percept PC DBS system in people with Major Depressive Disorder and Treatment Resistant Depression, run by Helen Mayberg, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellie Rapp (646-493-1607, ellie.rapp@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HDRS) score (time frame: baseline and up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773755, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.