Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
NCT ID: NCT01973478
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9 participants
INTERVENTIONAL
2014-06-03
2018-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DBS
The medical device includes:
* Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA)
* Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure.
The target is the Accumbens nucleus.
The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery.
The DBS is "on" during 6 months (between Month 1 and Month 7). Stimulation will also be on after Month 7.
DBS
SHAM
The medical device includes:
* Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA)
* Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure.
The target is the Accumbens nucleus.
The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery.
The DBS is "off" during 6 months (between Month 1 and Month 7). Possibility to active the stimulation after Month 7.
SHAM
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DBS
SHAM
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* DSM-IV (DSM = Diagnostic and Statistical Manual) criteria for a recurrent depressive disorder or bipolar disorder
* Duration of the episode \> 2 years
* Severity of the episode attested by :
* A HDRS score \> 21
* A CGI score ≥ 4
* A GAF \< 50
* Persistence of severity criteria during the screening
* Following characteristics resistance in case of recurrent depressive disorder :
* Stage V of the classification of Thase and Rush
* Unsuccessful treatment by the association of two antidepressants (or intolerance/contra-indications)
* Unsuccessful treatment by the association for at least 6 weeks of one of the following treatments : lithium , thyroid hormone , buspirone , pindolol with an antidepressant (or intolerance/contra-indications)
* Unsuccessful treatment by the combination of a second-generation antipsychotic (olanzapine, risperidone, amisulpride, aripiprazole, clozapine and quetiapine) to an antidepressant (or intolerance/contra-indications)
* Unsuccessful treatment by a structured psychotherapy
* Following characteristics of resistance in case of bipolar disorder:
* Unsuccessful treatment by lithium (or intolerance/contra-indications)
* Unsuccessful treatment by at least one mood stabilizer anticonvulsant (or intolerance/contra-indications)
* Unsuccessful treatment by at least one second-generation antipsychotic (or intolerance/contra-indications)
* Unsuccessful treatment by the combination of two mood stabilizers with at least an anticonvulsant (or intolerance/contra-indications)
* Unsuccessful treatment by electro-convulsive therapy sessions (or intolerance/contra-indications)
* Unsuccessful treatment by at least one antidepressant , mood stabilizer combination (or intolerance/contra-indications)
* Unsuccessful treatment by a structured psychotherapy
* Understanding the conduct of the study
* Giving a written informed consent
* Benefiting from the french social insurance
* Comorbid axis 1 disorder (except dysthymia, generalized anxiety disorder, social phobia, panic disorder)
* Alcohol or other psychoactive substances dependence (except nicotine)
* 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
* Suicide attempt in the last 6 months or two suicide attempts in the previous two years
* History of forensic act or furious mania
* Depressive episode with congruent or incongruent psychotic features or history of a depressive episode with psychotic features
* Comorbid cluster A or B personality disorders according to the DSM IV-TR evaluated using the SCID2 (Structured Clinical Interview for DSM-IV)
* Cognitive Impairment (Mattis \< 130)
* MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
* Major somatic disease making it impossible to set up the study treatment
* Pregnant women, or nursing or childbearing potential without effective contraception
* Involuntary commitment
* Guardianship
* Participation in another study
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rennes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean Michel Reymann
Role: STUDY_CHAIR
CIC INSERM 0203 CHU Rennes
Florian Naudet
Role: STUDY_CHAIR
CIC INSERM 0203 CHU Rennes
Bruno Millet
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Pitié-Salpêtrière
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
APHM
Marseille, , France
APHP Pitié Salpetriere
Paris, , France
CHS
Poitiers, , France
CHS
Rouen, , France
CHU
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35RC08_8902
Identifier Type: -
Identifier Source: org_study_id