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Major Depressive DisorderNCT03437928

DBS for Depression

A study testing Directional Deep Brain Stimulation in people with Major Depressive Disorder, run by Baylor College of Medicine at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Read more about this study

Who is it for?
Ages 22 to 70 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Directional Deep Brain Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
20 Aug 2019to 19 Aug 2027
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 22 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women (non-pregnant) between ages 22 and 70;
  • DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of major depression disorder (MDD) as the primary diagnosis. A current major depressive episode (MDE), recurrent or single episode with first episode before age 60, secondary to nonpsychotic unipolar major depressive disorder;
  • Chronic illness with current MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode >12 months);
  • Treatment resistance (defined by criteria on the Antidepressant Treatment History Form ATHF): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of four adequate depression treatments from at least two different treatment categories (e.g. SSRIs, SNRIs, TCAs, other antidepressants, lithium-addition, irreversible MAOIs, antidepressant augmentation with an atypical antipsychotic medication);
  • Previous trial of Electroconvulsive Therapy (ECT) (lifetime): either did not respond, relapsed, poorly tolerated or refused. If refused, will discuss reasons and ensure subject understands relative risks of ECT versus DBS. We will try to enrich sample with patients who had previously shown response to ECT (or another intervention) that was partial or un-sustained;
  • Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
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  • The HDRS17 must remain greater than or equal to 20 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
  • Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
  • Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;
  • Must have a brain MRI within 3 months of enrollment that is "normal", according to the radiology report, or does not reveal any findings that in the opinion of the Investigator preclude participation in the study;
  • Stable antidepressant medication regimen for the month preceding surgery;
  • Modified mini-mental state examination (MMSE) score ≥ 24;
  • Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
  • The patient does not have any medical or physical conditions which, in the opinion of the Investigator, make it unlikely the patient will be able to participate for the duration of the study;
  • Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;
  • Must have a treating psychiatrist, a family member, significant other/living partner, a caregiver, or a person known by the subject present at the Screening visit for the discussion about the study before co-signing the informed consent form;
  • Willingness to sign Treatment Contract;
  • Agrees to be followed at regular intervals by a licensed psychiatrist and to provide written permission allowing any and all forms of communication between the research team and the subject's healthcare providers, for the entirety of the study.

Who cannot join

  • DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
  • Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
  • Clinically significant Cluster A or B personality disorder;
  • Alcohol or substance use disorder within 6 months, excluding nicotine;
  • Urine drug test positive for illicit drugs;
  • Any evidence or indication of suicidal intent, suicidal attempt, or suicidal behavior, including but not limited to the C-SSRS score, within the past one year;
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  • Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation);
  • Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is known to lower seizure threshold, or other factors that predispose seizures);
  • Any medical contraindication to surgery such as infection;
  • Coagulopathy: Bleeding propensity and/or one of the following: INR > 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count < 100×103/uL;
  • A blood pressure of ≥ 180/110 mmHg at a single visit and evidence of cardiovascular disease (CVD);
  • Participation in another drug, device, or biological trial within 90 days;
  • Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
  • Pregnant or has plans to become pregnant in the next 24 months;
  • Anticipated need for MRI;
  • Need for Diathermy;
  • Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period;
  • Any Psychiatric/Neurological/Medical condition that makes the subject, in the opinion of the Investigator, a poor candidate.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims:

  1. Demonstrate device capability to selectively and predictably engage distinct brain networks
  2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation
  3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms
Read the detailed description

Treatment-resistant depression (TRD) is a major worldwide burden. Major depression has a lifetime prevalence of ~15% across developed countries. Up to a third of patients fail to respond adequately to evidence-based treatments, including pharmacological, behavioral, and electroconvulsive therapy. The investigators employ an innovative approach, including subacute invasive neurophysiological monitoring with which they aim to gain insight into the networks underlying depression symptomatology, confirm the ability to predict the effects of precision DBS on network activity, and harmonize these insights to implement network-guided DBS for TRD.

Being tested
Directional Deep Brain Stimulation
Keywords
Major Depressive Disorder (MDD), MDD, Neuromodulation, Deep Brain Stimulation (DBS), DBS, Electrophysiology, Imaging
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Directional Deep Brain StimulationDevice

    Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation

Study groups in NCT03437928
Study groupRoleWhat they receive
Directional Deep Brain StimulationExperimentalNot described
Receives: Device: Directional Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in depressive symptoms

    Response will be defined as 50% decrease in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline. The range is from 0 to 60 and a score higher than 20 indicates moderate to severe depression.

    Measured: 54 to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start20 Aug 2019
  3. Primary completion19 Aug 2027 (estimated)
  4. Study completion19 Aug 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437928
Sponsor's protocol ID
H-43036
Status last verified
Sep 2026
First submitted
9 Jan 2018
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Noecker AM, Mlakar J, Bijanki KR, Griswold MA, Pouratian N, Sheth SA, McIntyre CC. Stereo-EEG-guided network modulation for psychiatric disorders: Interactive holographic planning. Brain Stimul. 2023 Nov-Dec;16(6):1799-1805. doi: 10.1016/j.brs.2023.11.003. Epub 2023 Dec 20.

    PubMed 38135359

  • Powell MP, Anso J, Gilron R, Provenza NR, Allawala AB, Sliva DD, Bijanki KR, Oswalt D, Adkinson J, Pouratian N, Sheth SA, Goodman WK, Jones SR, Starr PA, Borton DA. NeuroDAC: an open-source arbitrary biosignal waveform generator. J Neural Eng. 2021 Feb 5;18(1):10.1088/1741-2552/abc7f0. doi: 10.1088/1741-2552/abc7f0.

    PubMed 33152715

Questions about this trial

What is this clinical trial studying?

A study testing Directional Deep Brain Stimulation in people with Major Depressive Disorder, run by Baylor College of Medicine at 2 sites 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 18 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in depressive symptoms (time frame: 54 to 60 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 NCT03437928, which also lists 2 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 1 Oct 2026.

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