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

NCT01569711 | Completed

• 1 other identifier: 2008-A00234-51
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Major Depressive Disorder, Recurrent, Unspecified

Keywords

chronic and resistant major depressive disorder; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• response after four months (M5) of DBS months defined as a 50% decrease in HDRS score

  The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.

  At 5 months after the DBS

Secondary Outcomes (8)

• Remission (defined as a score in the HDRS ≤ 7) after 4 months

  At 5 months after the DBS

• Duration of remission in the year of postoperative follow-up

  at one year of postoperative follow-up

• Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up

  at one year of postoperative follow-up

• Getting a score from 1 ("very much improved") or 2 ("strongly improved ") to item 2 of the Clinical Global Impression (CGI) during the year of postoperative follow-up

  at one year of postoperative follow-up

• Obtaining a score ≥ 60 at the level of Global Assessment of Functioning (GAF) during the year of postoperative follow-up

  at one year of postoperative follow-up

Study Arms (1)

Deep brain stimulation

Procedure: Deep brain stimulation of nucleus accumbens

Interventions

Deep brain stimulation of nucleus accumbens PROCEDURE

* 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)

Also known as: Non applicable.

Deep brain stimulation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a chronic and resistant major depressive disorder.

You may qualify if:

• Patients between 30 and 60 years old
• Meeting DSM-IV-TR for a major depressive disorder (MDD), recurrent (296.3x) diagnosed using the MINI scale
• Duration of the episode \> 2 years
• History of recurrent MDD (at least one prior episode index), authenticated by a report of ambulatory care or hospitalization
• Meeting Thase and Rush stage V for resistance (Thase and Rush 1997) (Annex 1 : mettre l'annexe)
• Presenting simultaneously an HDRS total score (17 items)\> 21, a GAF \<50, and a score of 4 on CGI despite the use of all the following strategies :
• monotherapy: 2 SSRIs, 1 ISRNA, 1 tricyclic (with measurement of plasma) at the maximum prescribed for a period of 8 weeks
• association at least one previous antidepressant, and for at least six weeks of one of the following treatment: lithium, thyroid hormone, buspirone, pindolol. An intolerance to one of these drug treatments related to its known side effects will be considered equivalent to the lack of effect of this treatment
• irreversible MAOI: iproniazid (Marsilid \*)
• combination of 2 antipsychotics, with at least a second generation antipsychotic (olanzapine, risperidone, amisulpride, aripiprazole or clozapine)
• combination of 2 antidepressants
• ECT: at least 8 sessions in maximal load with crisis GET\> 25 sec bilaterally. If not possible by cognitive impairment: unilateral
• structured psychotherapy inspired cognitive-behavioral or other type of structured psychotherapy for a period of one year
• Understanding of the study
• Giving their written, free and informed consent

You may not qualify if:

• Serious and unstable medical condition (cardiovascular, respiratory, endocrine, metabolic, liver, renal, hematologic, infectious, neurological or other ...) making impossible the establishment of study treatment
• Cognitive deterioration (Mattis \< 130)
• Abnormal brain standard MRI or contraindication for MRI
• Axis 1 disorder other than MDD (except generalized anxiety disorder, social phobia, panic disorder)
• Addiction to alcohol and other psychoactive substances with the exception of nicotine
• suicide risk in the last month (MINI 5.0.0: section suicide risk DIGS: section intent, premeditation, lethality) and score\> 2 in item 3 of HDRS
• MDD with psychotic features congruent or incongruent to the mood or an history of MDD with psychotic features
• Diagnostic criteria for personality disorders according to DSM-IV-TR Cluster A or B evaluated using the SCID2 (Maffei et al., 1997)
• Involuntary commitment, guardianship or trusteeship
• Women of childbearing without effective contraception

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (10)

Grenoble University Hospital (Nord Hospital)

Grenoble, France, 38043, France

Location

Bordeaux UH

Bordeaux, 33076, France

Location

Gabriel montpied University Hospital

Clermont-Ferrand, 63003, France

Location

Lille UH (Roger Salengro Hospital)

Lille, 59037, France

Location

Lyon UH (Pierre Wertheimer Hospital)

Lyon, 69394, France

Location

La Salpétrière UH

Paris, 75013, France

Location

Sainte Anne UH

Paris, 75014, France

Location

Poitiers UH

Poitiers, 86021, France

Location

Rennes UH

Rennes, 35703, France

Location

Toulouse UH

Toulouse, 31059, France

Location

Related Publications (1)

• Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Verin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.

  PMID: 24950819 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Millet MD Bruno

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: April 3, 2012
• Study Start: February 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

FR (10)