About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Abbott Laboratories Infinity™ implantable deep brain stimulation system
Treatment groups
Sponsors and collaborators
Nader Pouratian
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution