Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNader Pouratian
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Abbott Laboratories Infinity™ implantable deep brain stimulation system
DeviceDeep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Randomized Discontinuation Period: OFF then ON DBSExperimental treatment 1 intervention
Group B: Randomized Discontinuation Period: ON then OFF DBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Montgomery and Asberg Depression Rating Scale (MADRS) score.
The primary endpoint will be defined as at least a 40% reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) that measures depression severity. The MADRS scores range from 0 to 60, where increased values indicate more severe depression. There are 10 questions that each yield a score of 0-6 that are then summed for a total score.
Time frame
18 monthsSecondary outcomes
1
Change in another related clinical assessment: PHQ-9
Change in PHQ-9: Patient Health Questionnaire 9. The PHQ-9 the 9-item depression module from the full PHQ. Major depression is diagnosed if 5 or more of the 9 depressive symptom criteria have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. Other depression is diagnosed if 2, 3, or 4 depressive symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. One of the 9 symptom criteria ("thoughts that you would be better off dead or of hurting yourself in some way") counts if present at all, regardless of duration. The clinician is expected to rule out physical causes of depression, normal bereavement, and history of a manic episode. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Time frame
18 months2
Change in another related clinical assessment: QIDS-SR
Change in QIDS-SR: Quick Inventory of Depressive Symptomatology Self Report. The QIDS-SR is a 16-question shortened self-test, derived from the 30-item Inventory of Depressive Symptomatology (IDS), which measures 9 different criterion domains of major depression. Each of the 4 possible answers to each quiz is given an ascending numerical value from 0-3, where increased values indicate the severity of depressive symptom.
Time frame
18 months3
Change in another related clinical assessment: HAM-A
Change in HAM-A: Hamilton Anxiety Rating Scale. The HAM-A is a 14-item test designed to assess the severity of anxiety symptoms. All questions are rated on a 5-point (0-4) scale, with 7 questions on psychic anxiety and 7 questions on somatic anxiety. Total scores range from 0 to 56. Patients with anxiety and panic disorder tend to have a score greater than 20.
Time frame
18 months4
Change in another related clinical assessment: CSSRS
Change in CSSRS: Columbia Suicide-Severity Rating Scale. The C-SSRS is a semistructured clinical interview that utilizes a set of prompts and questions to help an interviewer get more complete information on events suggestive of suicidality. This prospective tool aims to standardize terminology and articulate suicidality assessment in a straightforward manner. The categories within the assessment involve binary responses (yes/no) that establish the intensity of suicide ideation on a scale of 1-5, where 5 is most severe.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nader Pouratian
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
Source ClinicalTrials.gov