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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01569711
First received: February 24, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Major Depressive Disorder, Recurrent, Unspecified
Procedure: Deep brain stimulation of nucleus accumbens

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • response after four months (M5) of DBS months defined as a 50% decrease in HDRS score [ Time Frame: At 5 months after the DBS ] [ Designated as safety issue: No ]
    The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.


Secondary Outcome Measures:
  • Remission (defined as a score in the HDRS ≤ 7) after 4 months [ Time Frame: At 5 months after the DBS ] [ Designated as safety issue: No ]
  • Duration of remission in the year of postoperative follow-up [ Time Frame: at one year of postoperative follow-up ] [ Designated as safety issue: No ]
  • Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up [ Time Frame: at one year of postoperative follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at one year of postoperative follow-up ] [ Designated as safety issue: No ]
  • Obtaining a score ≥ 60 at the level of Global Assessment of Functioning (GAF) during the year of postoperative follow-up [ Time Frame: at one year of postoperative follow-up ] [ Designated as safety issue: No ]
  • Changes in score on the scale of social adjustment in its self-assessment by (SAS-SR) in the year of postoperative follow-up [ Time Frame: at one year of postoperative follow-up ] [ Designated as safety issue: No ]
  • Evaluation of tolerance to treatment by clinicians, and by the patient and his family circle, reporting by the patient for adverse events at each follow-up visits after surgery, completion of the initial neuropsychological checkup [ Time Frame: at each follow-up visits after surgery ] [ Designated as safety issue: No ]
  • Effect of DBS at M9 after the DBS on caudate nucleus in case of non response at M5 after the DBS. [ Time Frame: at 9 months after the DBS ] [ Designated as safety issue: No ]
    The same scales (as described before) will be used at M9, to describe the effect of DBS on caudate nucleus.


Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Deep brain stimulation Procedure: Deep brain stimulation of nucleus accumbens
  • 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)
Other Name: Non applicable.

Detailed Description:

Depression is a common (12-Month Prevalence in the general population: 6%), recurrent and disabling disorder.

Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients not responding favorably to antidepressant medications, 50% would not benefit from ECT. For such patients, surgical interventions have been proposed in the past.

Many results support the hypothesis of a dysfunction of the functional loops between cortical and subcortical structures underlying the expression of depressive disorders.

Thus, therapeutic intervention focusing on these loops, in patients with chronic depression resistant to treatment, should be an issue and could improve prognosis of these patients.

As part of a maximal resistance to antidepressant drug, after failure of a series of bilateral ECT, a surgical functional intervention using DBS of nucleus accumbens is considered.

This open-label trial proposes to assess feasibility, safety and efficacy of DBS of nucleus accumbens in patients with chronic depression.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a chronic and resistant major depressive disorder.

Criteria

Inclusion Criteria:

  • 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
  • Affiliated to social security

Exclusion Criteria:

  • 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
  • More than two suicide attempts within two years prior to inclusion
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569711

Locations
France
Bordeaux UH
Bordeaux, France, 33076
Gabriel montpied University Hospital
Clermont-Ferrand, France, 63003
Grenoble University Hospital (Nord Hospital)
Grenoble, France, 38043
Lille UH (Roger Salengro Hospital)
Lille, France, 59037
Lyon UH (Pierre Wertheimer Hospital)
Lyon, France, 69394
La Salpétrière UH
Paris, France, 75013
Sainte Anne UH
Paris, France, 75014
Poitiers UH
Poitiers, France, 86021
Rennes UH
Rennes, France, 35703
Toulouse UH
Toulouse, France, 31059
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Millet MD Bruno Rennes University Hospital
  More Information

No publications provided by Rennes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01569711     History of Changes
Other Study ID Numbers: 2008-A00234-51
Study First Received: February 24, 2012
Last Updated: December 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
chronic and resistant major depressive disorder
deep brain stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Recurrence
Behavioral Symptoms
Disease Attributes
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014