Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
Eligible age
21–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.
Sponsor: Nader Pouratian
You may qualify if…
- ✓ Men and women (non-pregnant) between ages 21 and 70;
- ✓ DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder;
- ✓ Current index 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)28): Failure to respond to a minimum of four adequate depression treatments from different categories;
- ✓ Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
- ✓ Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op;
- ✓ Normal brain MRI within 3 months of surgery;
- ✓ Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS;
You may not qualify if…
- ✕ DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder;
- ✕ Alcohol or substance use disorder within 6 months, excluding nicotine;
- ✕ History of childhood abuse (physical or sexual) 18
- ✕ Personality disorders;
- ✕ Seeking disability during the trial;
- ✕ Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made any suicide attempt within the last year; (MADRS ≥ 5 including the day of surgery);
- ✕ No stable work history;
- ✕ Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate;
Where it's recruiting
Dallas
Source: ClinicalTrials.gov · NCT03952962 · last updated 2026-07-15