NCT01569711

Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder

Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depressive Disorder, Recurrent, Unspecified

Interventions

Type	Name	Description
PROCEDURE	Deep brain stimulation of nucleus accumbens	* Day0 : surgical placement of electrodes * M1 : stimulation of nucleus accumbens * M5 : stimulation of nucleus accumbens or associative territory of caudate nucleus (if no response observed with nucleus accumbens stimulation)

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-04-03
• Last updated: 2015-05-27

Locations

10 sites across 1 country: France