Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important. Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery. Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Because of their recurrent nature, their prevalence and their consequences, major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD), either unipolar (repeated episodes of depression) or bipolar (repeated episodes of depression and manic and/or hypomanic episodes). In these forms suicide risk is important. Patients with TRD are potential candidates for neurosurgical interventions to treat depression. The benefit of neurosurgical procedures is expected to be important in these patients. Psychosurgery interventions based upon lesions, however, showed their limitations related to 1/ the large variability in neurosurgical gestures, 2/ their side effects, and of course 3/ the irreversible damage caused by the surgery. Current brain imaging data yielded fresh information about the pathophysiology of depression and suggested new therapeutic approaches in TRD. Modulation of sub-caudate specific pathways, which are part of orbitofrontal and anterior cingulate cortico-subcortical loops should allow for a diminution of depressive symptoms. The modulation of these specific pathways, initially targeted by classical neurosurgery, could benefit from current developments in functional neurosurgery. Deep brain stimulation (DBS) may represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
APHM
Marseille, France
APHP Pitié Salpetriere
Paris, France
CHS
Poitiers, France
CHS
Rouen, France
CHU
Toulouse, France
Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no)
Response is defined as a 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version)
Time frame: Month 7
Remission (yes/no)
Remission is defined as an HDRS-17 score \< 7
Time frame: Month 7
CGI (Clinical global impressions) amelioration (yes/no)
Score of 1 or 2 (item 2 of the CGI)
Time frame: Month 7
GAF (Global assessment of functioning)
Presence of a score ≥ 60
Time frame: Month 7
HDRS-17 (Hamilton depression rating scale, 17 items version)
Score
Time frame: Month 7
MADRS (Montgomery-Asberg Depression Rating Scale)
Score
Time frame: Month 7
BDI (Beck Depression Inventory)
Score
Time frame: Month 7
CGI (Clinical global impressions)
Score
Time frame: Month 7
LARS (Lille Apathy Rating scale)
Score
Time frame: Month 7
GAF (Global assessment of functioning)
Score
Time frame: Month 7
Neuropsychological assessment
Time frame: Day -7 ; Month 1; Month 7; Month 13; Month 19; Month 24
Cerebral metabolism (PET scans)
Time frame: Day -7; Month 7
Adverse events
Adverse events occuring during the study.
Time frame: Month 24
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