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Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.
Depression is a common (12-Month Prevalence in the general population: 6%), recurrent and disabling disorder.
Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients not responding favorably to antidepressant medications, 50% would not benefit from ECT. For such patients, surgical interventions have been proposed in the past.
Many results support the hypothesis of a dysfunction of the functional loops between cortical and subcortical structures underlying the expression of depressive disorders.
Thus, therapeutic intervention focusing on these loops, in patients with chronic depression resistant to treatment, should be an issue and could improve prognosis of these patients.
As part of a maximal resistance to antidepressant drug, after failure of a series of bilateral ECT, a surgical functional intervention using DBS of nucleus accumbens is considered.
This open-label trial proposes to assess feasibility, safety and efficacy of DBS of nucleus accumbens in patients with chronic depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation of nucleus accumbens | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| response after four months (M5) of DBS months defined as a 50% decrease in HDRS score | The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score. | At 5 months after the DBS |
| Measure | Description | Time Frame |
|---|---|---|
| Remission (defined as a score in the HDRS ≤ 7) after 4 months | At 5 months after the DBS | |
| Duration of remission in the year of postoperative follow-up | at one year of postoperative follow-up | |
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Inclusion Criteria:
Patients between 30 and 60 years old
Meeting DSM-IV-TR for a major depressive disorder (MDD), recurrent (296.3x) diagnosed using the MINI scale
Duration of the episode > 2 years
History of recurrent MDD (at least one prior episode index), authenticated by a report of ambulatory care or hospitalization
Meeting Thase and Rush stage V for resistance (Thase and Rush 1997) (Annex 1 : mettre l'annexe)
Presenting simultaneously an HDRS total score (17 items)> 21, a GAF <50, and a score of 4 on CGI despite the use of all the following strategies :
Understanding of the study
Giving their written, free and informed consent
Affiliated to social security
Exclusion Criteria:
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Patients with a chronic and resistant major depressive disorder.
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| Name | Affiliation | Role |
|---|---|---|
| Millet MD Bruno | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital (Nord Hospital) | Grenoble | France | 38043 | France | ||
| Bordeaux UH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24950819 | Derived | Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Verin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20. |
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|
|
| Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up |
| at one year of postoperative follow-up |
| Getting a score from 1 ("very much improved") or 2 ("strongly improved ") to item 2 of the Clinical Global Impression (CGI) during the year of postoperative follow-up | at one year of postoperative follow-up |
| Obtaining a score ≥ 60 at the level of Global Assessment of Functioning (GAF) during the year of postoperative follow-up | at one year of postoperative follow-up |
| Changes in score on the scale of social adjustment in its self-assessment by (SAS-SR) in the year of postoperative follow-up | at one year of postoperative follow-up |
| Evaluation of tolerance to treatment by clinicians, and by the patient and his family circle, reporting by the patient for adverse events at each follow-up visits after surgery, completion of the initial neuropsychological checkup | at each follow-up visits after surgery |
| Effect of DBS at M9 after the DBS on caudate nucleus in case of non response at M5 after the DBS. | The same scales (as described before) will be used at M9, to describe the effect of DBS on caudate nucleus. | at 9 months after the DBS |
| Bordeaux |
| 33076 |
| France |
| Gabriel montpied University Hospital | Clermont-Ferrand | 63003 | France |
| Lille UH (Roger Salengro Hospital) | Lille | 59037 | France |
| Lyon UH (Pierre Wertheimer Hospital) | Lyon | 69394 | France |
| La Salpétrière UH | Paris | 75013 | France |
| Sainte Anne UH | Paris | 75014 | France |
| Poitiers UH | Poitiers | 86021 | France |
| Rennes UH | Rennes | 35703 | France |
| Toulouse UH | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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