Ignite Creation Date:
2024-05-06 @ 2:07 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01973478
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2013-10-08
Brief Title:
Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STHYM
Brief Summary:
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
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
Detailed Description:
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None