Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criterias

History of forensic act or furious mania
Involuntary commitment
Suicidal risk during the last month assessed by the MINI (Mini International Neuropsychiatric Interview), the DIGS (Diagnostic Interview for Genetic Studies) and the item 3 of the HDRS
...
History of forensic act or furious mania
Involuntary commitment
Suicidal risk during the last month assessed by the MINI (Mini International Neuropsychiatric Interview), the DIGS (Diagnostic Interview for Genetic Studies) and the item 3 of the HDRS
MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
Comorbid axis 1 disorder (except dysthymia, generalized anxiety disorder, social phobia, panic disorder)
Participation in another study
Cognitive Impairment (Mattis < 130)
Comorbid cluster A or B personality disorders according to the DSM IV-TR evaluated using the SCID2 (Structured Clinical Interview for DSM-IV)
Suicide attempt in the last 6 months or two suicide attempts in the previous two years
Depressive episode with congruent or incongruent psychotic features or history of a depressive episode with psychotic features
Major somatic disease making it impossible to set up the study treatment
Alcohol or other psychoactive substances dependence (except nicotine)
Guardianship
Pregnant women, or nursing or childbearing potential without effective contraception

Summary

Conditions
  • Bipolar Disorder
  • Major Depressive Disorder
  • Recurrent Depressive Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 bipola...

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.

Inclusion Criterias

History of forensic act or furious mania
Involuntary commitment
Suicidal risk during the last month assessed by the MINI (Mini International Neuropsychiatric Interview), the DIGS (Diagnostic Interview for Genetic Studies) and the item 3 of the HDRS
...
History of forensic act or furious mania
Involuntary commitment
Suicidal risk during the last month assessed by the MINI (Mini International Neuropsychiatric Interview), the DIGS (Diagnostic Interview for Genetic Studies) and the item 3 of the HDRS
MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
Comorbid axis 1 disorder (except dysthymia, generalized anxiety disorder, social phobia, panic disorder)
Participation in another study
Cognitive Impairment (Mattis < 130)
Comorbid cluster A or B personality disorders according to the DSM IV-TR evaluated using the SCID2 (Structured Clinical Interview for DSM-IV)
Suicide attempt in the last 6 months or two suicide attempts in the previous two years
Depressive episode with congruent or incongruent psychotic features or history of a depressive episode with psychotic features
Major somatic disease making it impossible to set up the study treatment
Alcohol or other psychoactive substances dependence (except nicotine)
Guardianship
Pregnant women, or nursing or childbearing potential without effective contraception

Locations

Toulouse
Poitiers
Rouen
Paris
Marseille
...
Toulouse
Poitiers
Rouen
Paris
Marseille

Tracking Information

NCT #
NCT01973478
Collaborators
Not Provided
Investigators
  • Study Chair: Jean Michel Reymann CIC INSERM 0203 CHU Rennes Study Chair: Florian Naudet CIC INSERM 0203 CHU Rennes Principal Investigator: Bruno Millet Groupe Hospitalier Pitié-Salpêtrière
  • Study Chair: Jean Michel Reymann CIC INSERM 0203 CHU Rennes Study Chair: Florian Naudet CIC INSERM 0203 CHU Rennes Bruno Millet Groupe Hospitalier Pitié-Salpêtrière