Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression (NCT02046330) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
United States16 participantsStarted 2013-12-16
Plain-language summary
We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Perceptâ„¢ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.
Who can participate
Age range22 Years – 70 Years
SexALL
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Inclusion criteria
✓. Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity.
✓. Age 22 - 70 years.
✓. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items
✓. Global Assessment of Function (GAF) score of 45 or less.
✓. A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior).
✓. Failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials ( equal\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
✓
What they're measuring
1
Changes in patients MADRS scores
Timeframe: weekly (24 Months)
Trial details
NCT IDNCT02046330
SponsorThe University of Texas Health Science Center, Houston
. Able to comply with the operational and administrative requirements of participation in the study.
✓. Able to give written informed consent
Exclusion criteria
✕. Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis.
✕. Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
✕. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
✕. Any previous surgery to destroy the region of the brain that will be the target of treatment.
✕. Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
✕. Refusal of an adequate trial of ECT.
✕. History of stimulation intolerance in any area of the body.
✕. Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.