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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01973478
Other study ID # 35RC08_8902
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2014
Est. completion date November 27, 2018

Study information

Verified date December 2019
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date November 27, 2018
Est. primary completion date July 3, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age between 18 and 70 years

- 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

Non-Inclusion Criteria:

- 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

Study Design


Intervention

Device:
DBS

SHAM


Locations

Country Name City State
France APHM Marseille
France APHP Pitié Salpetriere Paris
France CHS Poitiers
France CHS Rouen
France CHU Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other HDRS-17 (Hamilton depression rating scale, 17 items version) Longitudinal evolution of the score Month -3 ; Month -1; Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24
Other MADRS (Montgomery-Asberg Depression Rating Scale) Longitudinal evolution of the score Month -3 ; Month -1; Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24
Other BDI (Beck Depression Inventory) Longitudinal evolution of the score Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24
Other CGI (Clinical global impressions) Longitudinal evolution of the score Month -3 ; Month -1; Day-7; Day15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24
Other LARS (Lille Apathy Rating scale) Longitudinal evolution of the score Day -7; Month 1; Month 7; Month 13; Month 19; Month 24
Other GAF (Global assessment of functioning) Longitudinal evolution of the score Month -3 ; Month -1; Day -7; Month 1; Month 7; Month 13; Month 19; Month 24
Other YMRS (Young Mania Rating Scale) Longitudinal evolution of the score Day -7; Month 1; Month 7; Month 13; Month 19; Month 24
Other MATHYS (Multidimensional Assessment of Thymic States) Longitudinal evolution of the score Day -7; Month 1; Month 7; Month 13; Month 19; Month 24
Other Response (50 % decrease of the HDRS-17) During the whole follow up Month 24
Other Remission During the whole follow up Remission is defined as an HDRS-17 score < 7 M24
Primary Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no) Response is defined as a 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) Month 7
Secondary Remission (yes/no) Remission is defined as an HDRS-17 score < 7 Month 7
Secondary CGI (Clinical global impressions) amelioration (yes/no) Score of 1 or 2 (item 2 of the CGI) Month 7
Secondary GAF (Global assessment of functioning) Presence of a score = 60 Month 7
Secondary HDRS-17 (Hamilton depression rating scale, 17 items version) Score Month 7
Secondary MADRS (Montgomery-Asberg Depression Rating Scale) Score Month 7
Secondary BDI (Beck Depression Inventory) Score Month 7
Secondary CGI (Clinical global impressions) Score Month 7
Secondary LARS (Lille Apathy Rating scale) Score Month 7
Secondary GAF (Global assessment of functioning) Score Month 7
Secondary Neuropsychological assessment Day -7 ; Month 1; Month 7; Month 13; Month 19; Month 24
Secondary Cerebral metabolism (PET scans) Day -7; Month 7
Secondary Adverse events Adverse events occuring during the study. Month 24
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