Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 10
- 主要终点
- response after four months (M5) of DBS months defined as a 50% decrease in HDRS score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
response after four months (M5) of DBS months defined as a 50% decrease in HDRS score
时间窗: At 5 months after the DBS
The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.
次要结局
- 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)
- Changes in score on the scale of social adjustment in its self-assessment by (SAS-SR) in the year of postoperative follow-up(at one year of postoperative follow-up)
- 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(at each follow-up visits after surgery)
- Effect of DBS at M9 after the DBS on caudate nucleus in case of non response at M5 after the DBS.(at 9 months after the DBS)