Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder (PRESTHYM)
|ClinicalTrials.gov Identifier: NCT01569711|
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder, Recurrent, Unspecified||Procedure: Deep brain stimulation of nucleus accumbens|
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.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|Deep brain stimulation||
Procedure: Deep brain stimulation of nucleus accumbens
Other Name: Non applicable.
- response after four months (M5) of DBS months defined as a 50% decrease in HDRS score [ Time Frame: At 5 months after the DBS ]The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.
- Remission (defined as a score in the HDRS ≤ 7) after 4 months [ Time Frame: At 5 months after the DBS ]
- Duration of remission in the year of postoperative follow-up [ Time Frame: at one year of postoperative follow-up ]
- Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: at 9 months after the DBS ]The same scales (as described before) will be used at M9, to describe the effect of DBS on caudate nucleus.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569711
|Bordeaux, France, 33076|
|Gabriel montpied University Hospital|
|Clermont-Ferrand, France, 63003|
|Grenoble University Hospital (Nord Hospital)|
|Grenoble, France, 38043|
|Lille UH (Roger Salengro Hospital)|
|Lille, France, 59037|
|Lyon UH (Pierre Wertheimer Hospital)|
|Lyon, France, 69394|
|La Salpétrière UH|
|Paris, France, 75013|
|Sainte Anne UH|
|Paris, France, 75014|
|Poitiers, France, 86021|
|Rennes, France, 35703|
|Toulouse, France, 31059|
|Principal Investigator:||Millet MD Bruno||Rennes University Hospital|