DBS for Depression
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorBaylor College of Medicine
About this trial
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
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Directional Deep Brain Stimulation
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Baylor College of Medicine
Lead sponsor
University of Texas
Collaborator
Source ClinicalTrials.gov