Treatment Resistant DepressionPhase 1NCT06096207
DBS for Depression
A Phase 1 study testing Medtronic SenSight Directional DBS lead in people with Treatment Resistant Depression, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: Is deep brain stimulation effective in treating treatment resistant depression? Does deep brain stimulation improve overall clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Medtronic SenSight Directional DBS lead
- 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
- 18 Oct 2023to 18 Oct 2038
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depression Disorder (MDD) or Bipolar Disorder (I /II) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)
- Age 18 - 65 years.
- 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and/or Montgomery-Asburg Depression Rating Scale (MADRS) score of at least 21.
- World Health Organization Disability Assessment Scale 2.0(WHODAS2.0) score of 19 or more
- A recurrent (equal or >4 episodes) or chronic (episode duration equal or higher >2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior) over lifetime history as determined by an investigator
- As determined by the study psychiatrist/investigator, has treatment resistant depression defined as failure to respond to: 6.1. Adequate trials (equal or >6 weeks at an adequate dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials (equal>4 weeks at an adequate dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants,neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
Show all 15Show fewer
- Able to comply with the operational and administrative requirements of participation in the study.
- Able to give written informed consent
- Major Depressive Disorder (MDD) or Bipolar Disorder (I/II) is the primary psychiatric diagnosis in the medical opinion of an investigator.
- On a stable psychiatric medication regimen beginning at least 6 weeks prior to enrollment and continuing through the first 6 months of the study, as determined by the investigator. Psychiatric medication changes can be made during the entirety of the subject's study participation but would be limited to the clinical judgment of the PI/study psychiatrist.
- At enrollment, provides the following information from at least two (2) verifiable contacts who reside within a 10-mile radius of the patient: name, relationship to patient, address (email mail); and telephone (mobile, home, work as applicable).
- Agrees to allow medical records requests and communications of any type to any and all health care providers who have seen the patient within five years of screening or enrollment.
- For the duration of study participation, agrees to be followed by a licensed psychiatrist and/or other licensed mental health practitioner on a regularly scheduled basis.
- FOR AGES 18-21: An average of at least 3 in the following subdomains on the Psychological Maturity Scale (PMS): questions 1-6, "Ego Resilience"; questions 7-13, "Self-Awareness"; questions 14-17, "Autonomy"; questions 18-21, Flexibility".
- FOR AGES 18-21: Residing with a caretaker or having oversight of a caretaker.
Who cannot join
- Patients with any lifetime history of psychosis or psychotic disorder, according to DSM-V diagnostic criteria, or in the medical opinion of the PI/study psychiatrist.
- Any finding on the preoperative magnetic resonance imaging (MRI) scan that, in the opinion of the principal investigator and after consultation with the neuroradiologist, is, or might be, considered clinically significant such that participation in the study: (a) seems likely to increase the medical risk to the subject sufficient to outweigh the potential benefit to study participation; (b) seems likely to jeopardize the subject's ability to complete the study or fulfill all study requirements per protocol; or (c) may impact he integrity of the data or the validity of the results.
- Any previous surgery to destroy the treatment target (superolateral MFB) rendering it either unilaterally or bilaterally damaged such that it cannot be effectively stimulated, as visualized by pre-operative MRI scans, in the medical opinion of the PI
- Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/orinability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantablestimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. DBS contraindications include patients who are unable to properly operate the neurostimulator, and patientswho will be exposed to MRI or diathermy. MRI and diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) are contraindicated because the energy can be transferred through the implanted System (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.
- Refusal of an adequate trial of ECT in the medical opinion of the study psychiatrist or PI following consultation with a study psychiatrist.
- History of stimulation intolerance in any area of the body.
Show all 18Show fewer
- Within six (6) months of the enrollment date, has been diagnosed with, or has met the diagnostic criteria for, a substance abuse disorder (SUD) according to DSM-V criteria.
- Women of childbearing potential who, at enrollment or during the study: (a)have a positive urine pregnancy test; (b) are heterosexually active without the usage of a medically acceptable, highly effect contraceptive method* (≤1% pregnancy rate); or (c) are planning to become pregnant during the 60-month course of this study, as determined by the PI. *Examples include tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), and long-acting reversible contraceptives (LARC).
- 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.
- Participation in another drug, device, or biologics trial within the preceding 30 days
- Presence of a condition requiring routine MRIs.
- Presence of a condition requiring diathermy.
- Subject is on anticoagulant medication.
- Prior to enrollment or during the course of the study and in the opinion of the PI, has a history of an medical, psychiatric, physical or non-physical disease, disorder, condition, injury, or disability; or has a non-medical reason (e.g., financial, logistical, personal, other) that: (a) may pose a significant risk to the patient; (b) may increase the possibility that the subject is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) may adversely impact the integrity of the data or the validity of the study results.
- Subjects without a fixed home address or stable living situation, in the opinion of the Principal Investigator.
- Subjects involved in activities involving significant radiation exposure in the past year.
- Receiving TMS after DBS implantation
- Any mania or manic episodes within 5 years of enrollment according to DSM-V diagnostic criteria, or in the medical opinion of the PI/study psychiatrist
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
Zucker Hillside Hospital
Queens, New York, 11004
Samantha Gonzalez, 718-470-4152, sgonzalez30@northwell.edu
Albert J Fenoy, MD
About this study
Official title: Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are:
- Is deep brain stimulation effective in treating treatment resistant depression?
- Does deep brain stimulation improve overall clinical well-being and functioning?
Read more
Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year.
Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
Read the detailed description
This initial study at Northwell Health has the purpose to demonstrate the feasibility and safety of performing slMFB DBS as a treatment for TRD at Northwell Health as well as more clearly establish efficacy. The investigators hypothesize that DBS targeting can be consistently placed in the supero-lateral branch of the medial forebrain bundle (slMFB) after identification using diffusion tensor imaging and fiber tract analysis, as performed in DBS at UTHealth. The investigators will implant the Medtronic SenSight Directional DBS lead at this target location.
- Conditions
- Treatment Resistant Depression
- Being tested
- Medtronic SenSight Directional DBS lead
- Keywords
- TRD
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic SenSight Directional DBS leadDevice
At the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded.
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation Phase Group 1 | Experimental | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. Receives: Device: Medtronic SenSight Directional DBS lead |
| Discontinuation Phase Group 2 | Experimental | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. Receives: Device: Medtronic SenSight Directional DBS lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is the Montgomery-Asberg Depression Rating Scale, which at 12 months will be the primary endpoint. The investigators hypothesize is that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on MADRS scores. Also, that at 12 months 50% of the patients will be responders.
Measured: 12 months
Secondary outcomes (3)
World Health Organization Disability Assessment Scale 2.0 (WHODAS2.0)
WHODAS2.0 measures functional impairment. The investigators hypothesize that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on WHODAS2.0 scores.
Measured: 12 months
Clinical Global Impressions (CGI) rated severity
CGI is a clinician-determined summary based on all available information including severity, global improvement or change, and therapeutic response. The investigators hypothesize that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on CGI.
Measured: 12 months
Measuring MADRS during discontinuation cross over weeks
Depression scores when the device is turned ON verses OFF, as assessed by the MADRS sale. The investigators hypothesize that MADRS values will differ significantly during the two-week period of discontinuation versus the 4-week period of ON.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start18 Oct 2023
- Primary completion18 Oct 2030 (estimated)
- Study completion18 Oct 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Albert J Fenoy, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096207
- Sponsor's protocol ID
- 23-0209
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fenoy AJ, Schulz P, Selvaraj S, Burrows C, Spiker D, Cao B, Zunta-Soares G, Gajwani P, Quevedo J, Soares J. Deep brain stimulation of the medial forebrain bundle: Distinctive responses in resistant depression. J Affect Disord. 2016 Oct;203:143-151. doi: 10.1016/j.jad.2016.05.064. Epub 2016 Jun 3.
PubMed 27288959Fenoy AJ, Schulz PE, Selvaraj S, Burrows CL, Zunta-Soares G, Durkin K, Zanotti-Fregonara P, Quevedo J, Soares JC. A longitudinal study on deep brain stimulation of the medial forebrain bundle for treatment-resistant depression. Transl Psychiatry. 2018 Jun 4;8(1):111. doi: 10.1038/s41398-018-0160-4.
PubMed 29867109Fenoy AJ, Schulz PE, Sanches M, Selvaraj S, Burrows CL, Asir B, Conner CR, Quevedo J, Soares JC. Deep brain stimulation of the "medial forebrain bundle": sustained efficacy of antidepressant effect over years. Mol Psychiatry. 2022 May;27(5):2546-2553. doi: 10.1038/s41380-022-01504-y. Epub 2022 Mar 14.
PubMed 35288633
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT06096207
- Acronym / sponsor ID
- 23-0209
- Conditions
- Treatment Resistant Depression
- Keywords
- TRD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 18 Oct 2030 (estimated)
- Study completion
- 18 Oct 2038 (estimated)
- First posted
- 23 Oct 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.
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are:
- Is deep brain stimulation effective in treating treatment resistant depression?
- Does deep brain stimulation improve overall clinical well-being and functioning?
Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year.
Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
Detailed description
This initial study at Northwell Health has the purpose to demonstrate the feasibility and safety of performing slMFB DBS as a treatment for TRD at Northwell Health as well as more clearly establish efficacy. The investigators hypothesize that DBS targeting can be consistently placed in the supero-lateral branch of the medial forebrain bundle (slMFB) after identification using diffusion tensor imaging and fiber tract analysis, as performed in DBS at UTHealth. The investigators will implant the Medtronic SenSight Directional DBS lead at this target location.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation Phase Group 1 | Experimental | Device: Medtronic SenSight Directional DBS leadPatients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
| Discontinuation Phase Group 2 | Experimental | Device: Medtronic SenSight Directional DBS leadPatients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Major Depression Disorder (MDD) or Bipolar Disorder (I /II) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)
- Age 18 - 65 years.
- 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and/or Montgomery-Asburg Depression Rating Scale (MADRS) score of at least 21.
- World Health Organization Disability Assessment Scale 2.0(WHODAS2.0) score of 19 or more
- A recurrent (equal or >4 episodes) or chronic (episode duration equal or higher >2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior) over lifetime history as determined by an investigator
Key exclusion criteria (18 listed)
- Patients with any lifetime history of psychosis or psychotic disorder, according to DSM-V diagnostic criteria, or in the medical opinion of the PI/study psychiatrist.
- Any finding on the preoperative magnetic resonance imaging (MRI) scan that, in the opinion of the principal investigator and after consultation with the neuroradiologist, is, or might be, considered clinically significant such that participation in the study: (a) seems likely to increase the medical risk to the subject sufficient to outweigh the potential benefit to study participation; (b) seems likely to jeopardize the subject's ability to complete the study or fulfill all study requirements per protocol; or (c) may impact he integrity of the data or the validity of the results.
- Any previous surgery to destroy the treatment target (superolateral MFB) rendering it either unilaterally or bilaterally damaged such that it cannot be effectively stimulated, as visualized by pre-operative MRI scans, in the medical opinion of the PI
- Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/orinability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantablestimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. DBS contraindications include patients who are unable to properly operate the neurostimulator, and patientswho will be exposed to MRI or diathermy. MRI and diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) are contraindicated because the energy can be transferred through the implanted System (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.
- Refusal of an adequate trial of ECT in the medical opinion of the study psychiatrist or PI following consultation with a study psychiatrist.
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 SenSight Directional DBS leadAt the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded. | Device | Discontinuation Phase Group 1, Discontinuation Phase Group 2 |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 12 months
The MADRS is the Montgomery-Asberg Depression Rating Scale, which at 12 months will be the primary endpoint. The investigators hypothesize is that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on MADRS scores. Also, that at 12 months 50% of the patients will be responders.
3 secondary outcomes
World Health Organization Disability Assessment Scale 2.0 (WHODAS2.0)
Time frame: 12 months
Clinical Global Impressions (CGI) rated severity
Time frame: 12 months
Measuring MADRS during discontinuation cross over weeks
Time frame: 6 weeks
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 14 Sep 2026.
- Background: PubMed 27288959Fenoy AJ, Schulz P, Selvaraj S, Burrows C, Spiker D, Cao B, Zunta-Soares G, Gajwani P, Quevedo J, Soares J. Deep brain stimulation of the medial forebrain bundle: Distinctive responses in resistant depression. J Affect Disord. 2016 Oct;203:143-151. doi: 10.1016/j.jad.2016.05.064. Epub 2016 Jun 3.
- Background: PubMed 29867109Fenoy AJ, Schulz PE, Selvaraj S, Burrows CL, Zunta-Soares G, Durkin K, Zanotti-Fregonara P, Quevedo J, Soares JC. A longitudinal study on deep brain stimulation of the medial forebrain bundle for treatment-resistant depression. Transl Psychiatry. 2018 Jun 4;8(1):111. doi: 10.1038/s41398-018-0160-4.
- Background: PubMed 35288633Fenoy AJ, Schulz PE, Sanches M, Selvaraj S, Burrows CL, Asir B, Conner CR, Quevedo J, Soares JC. Deep brain stimulation of the "medial forebrain bundle": sustained efficacy of antidepressant effect over years. Mol Psychiatry. 2022 May;27(5):2546-2553. doi: 10.1038/s41380-022-01504-y. Epub 2022 Mar 14.
Related trials for Treatment Resistant Depression
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Treatment-resistant Depression (TRD)
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 3
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
Treatment Resistant Depression
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide
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.
Albert J Fenoy, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medtronic SenSight Directional DBS lead in people with Treatment Resistant Depression, run by Northwell Health 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 15 inclusion and 18 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 14 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jeanna Boltz (7184708021, Jboltz@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 12 months). 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 NCT06096207, which also lists 3 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 14 Sep 2026.