F33.2 F33.3 F33.8 F33.9
Conditions
Interventions
Group 1: ALL PATIENTS:
Implantation of Vercise™ GEVIATM deep brain stimulation (DBS) system. “Bioelectric activity” testing in a sub-group of 6 patients.
RANDOMIZED STIMULATION ONSET:
Group A: DBS on
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this trial must meet all of the following criteria: 1)Major depression (MD), severe, unipolar, or bipolar in an acute depression episode. 2)German mother tongue or fluent. 3)Male or female patients =20 and =75 years. 4)Hamilton Depression Rating Scale (HDRS-28) score of >21. 5)Global Assessment of Function (GAF) score of 2 years. 7)Failure to respond to a.adequate trials of primary antidepressants from at least 3 different classes (>5 weeks at the maximum recommended or tolerated dose) and b.adequate trials of augmentation/combination of a primary antidepressant (>3 weeks at the usually recommended or maximum tolerated dose) using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) and c.an adequate trial of electroconvulsive therapy (ECT) (>6 treatments) and an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist). 8)Able to give written informed consent. 9)Compliance to participate in the study. 10)Drug free or on stable drug regimen at least 6 weeks before study entry.
Exclusion criteria
Exclusion criteria: 1)Current or past non-affective psychotic disorder. 2)Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome. 3)Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI), any contraindications to perform a planned MRI to visualize the slMFB. 4)Any surgical contraindications to undergoing DBS like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation, present risks for anesthesia or any brain or scalp injury (even after intracranial surgery). 5)Current or unstably remitted substance abuse (aside from nicotine). 6)Pregnancy, women of childbearing age not using effective contraception and breast feeding women. 7)History of severe personality disorder. 8)Acute suicidal ideation. 9)Patients with advanced stage cardiovascular disease. 10)Patients under immunosuppressive or chemo therapy because of malignant disease. 11)Patients who had previous intracranial surgery. 12)Patients who are currently under DBS therapy or have implanted any kind of stimulator already. 13)Patients with aneurysm clips. 14)Patients with cochlear implants. 15)Patients with planned diathermy. 16)Persons who are in a relationship of dependence/employment with the sponsor or the investigator. 17)Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (Efficacy): MADRS at 16 weeks after surgery Primary endpoint (2nd stage): Time to MADRS augmentation of >5 points or clinical worsening in two consecutive visits after DBS termination Primary endpoint (safety): Assessment of (Serious) Adverse Events related to Investigational Medical Device and / or surgical procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| After randomized step: a)HDRS, CGI, GAF, BDI-II, SF-36 at 16 weeks after surgery. b)Change over time in HDRS, CGI, GAF, BDI-II, SF-36 after DBS surgery with DB stimulation OFF compared to stimulation ON. c)Scores in neuropsychological tests (sham vs. DBS) at 4 months. In whole population after 6 months stimulation: d)MADRS / HDRS during long-term follow-up (at 6 months open stimulation) compared to baseline. e)Scores in CGI, GAF, BDI-II, SF-36 at 6 and 12 months DBS compared to baseline. f)Scores in neuropsychological tests at 6 months DBS compared to baseline and at end of the study compared to baseline. g)Incidence of relapse into clinical depression after tapering down of DBS. | — |
Countries
Germany
Contacts
Public ContactThomas Schläpfer
Universitätsklinikum FreiburgKlinik für Psychiatrie und PsychotherapieAbteilung für Interventionelle Biologische Psychiatrie
Outcome results
None listed