Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
Condition: Major Depressive Disorder; Recurrent Depressive Disorder; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

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.
    

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
      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.
    

Intervention name(s): DBS; SHAM
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; Recurrent depressive disorder; Bipolar disorder; Deep brain stimulation; Accumbens