DBS for Depression
Eligible age
22–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Baylor College of Medicine
You may qualify if…
- ✓ 1. Men and women (non-pregnant) between ages 22 and 70;
- ✓ 2. 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;
- ✓ 3. 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);
- ✓ 4. 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);
- ✓ 5. 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;
- ✓ 6. Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
- ✓ 7. 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;
- ✓ 8. Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
You may not qualify if…
- ✕ 1. DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
- ✕ 2. Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
- ✕ 3. Clinically significant Cluster A or B personality disorder;
- ✕ 4. Alcohol or substance use disorder within 6 months, excluding nicotine;
- ✕ 5. Urine drug test positive for illicit drugs;
- ✕ 6. 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;
- ✕ 7. 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);
- ✕ 8. 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);
Where it's recruiting
Dallas · Houston
Source: ClinicalTrials.gov · NCT03437928 · last updated 2026-07-30