Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jan 23, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Deep Brain Stimulation (DBS) for people who have Major Depressive Disorder that hasn't improved with other treatments, known as treatment-resistant depression. The research focuses on a specific area of the brain called the medial forebrain bundle, which previous studies suggest might help alleviate depression symptoms. The trial will include about 20 patients aged 22 to 70 who have tried multiple therapies, such as medications and electroconvulsive therapy (ECT), but still experience significant depression.

To participate in this study, individuals must have a severe form of depression that has lasted for a long time and have experienced at least four episodes of depression over their lifetime. They should also be in good general health and on a stable medication regimen for at least six weeks prior to joining the study. Participants will undergo a procedure using the Percept™ PC system from Medtronic to see if DBS can help improve their mood and overall functioning. It’s important to note that this trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity.
• • 2. Age 22 - 70 years.
• • 3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items
• • 4. Global Assessment of Function (GAF) score of 45 or less.
• • 5. 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).
• • 6. 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).
• • 7. Able to comply with the operational and administrative requirements of participation in the study.
• • 8. Able to give written informed consent
• • 9. On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study.
• • 10. Good general health. No changes in medication treatment during participation in study.
• Exclusion Criteria:
• • 1. 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.
• • 2. Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
• • 3. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• • 4. Any previous surgery to destroy the region of the brain that will be the target of treatment.
• • 5. 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.
• • 6. Refusal of an adequate trial of ECT.
• • 7. History of stimulation intolerance in any area of the body.
• • 8. Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.
• • 9. Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required.
• • 10. History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder.
• • 11. Imminent risk of suicide
• • 12. Participation in another drug, device, or biologics trial within the preceding 30 days
• • 13. Presence of a condition requiring routine MRIs.
• • 14. Presence of a condition requiring diathermy.
• • 15. Subject is on anticoagulant medication.
• • 16. Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).
• • 17. Terminal illness associated with expected survival of \<12 months.