Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder (PRESTHYM)
This study is ongoing, but not recruiting participants.
Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01569711
First received: February 24, 2012
Last updated: December 3, 2012
Last verified: December 2012
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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 |
Resource links provided by NLM:
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: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Deep brain stimulation |
Procedure: Deep brain stimulation of nucleus accumbens
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
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
| 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 3, 2012 |
| 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:
|
Depressive Disorder Depression Depressive Disorder, Major Recurrence Mood Disorders |
Mental Disorders Behavioral Symptoms Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013