NCT03347487终止不适用
Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- changes in the Montgomery-Asberg Depression Rating Scale from baseline to 9 months
研究概览
简要总结
The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness and safety of bilateral DBS to habenula for patients with TRD. This study will also use structural and functional MRI to explore the underlying mechanism of Hb's effects on TRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women(non-pregnant) aged 18-65 years old;
- •DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5) of a current major depressive episode(MDE), either nonpsychotic unipolar major depressive disorder (MDD) or bipolar disorder (BD);
- •Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months) and a minimum of 5 y since the onset of the first depressive episode;
- •For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder)
- •Treatment resistance defined as Failure of at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA+, lithium-addition) for a period of 6-8 weeks. If diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
- •At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT). Or unable to recieve ECT.
- •Symptom Severity: HAMD-17 total ≥21;
- •Stable antidepressant medical regimen for the month preceding surgery;
- •Anticipates a stable psychotropic medication regimen in the next 12 months;
- •Able and willing to give written informed consent;
- •Modified mini-mental state examination (MMSE) score ≥ 27；
排除标准
- •Schizophrenia /history of psychosis unrelated to MDD;
- •Severe personality disorder (assessed by SCID-II);
- •Alcohol or substance abuse/dependence within 6 months, excluding nicotine dependence;
- •Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year;
- •Neurological disease (e.g., Parkinson's disease)
- •Any history of seizure disorder or hemorrhagic stroke;
- •Abnormal brain MRI ;
- •Previous sterosurgery;
- •Any medical contraindication to surgery;
- •Does not have adequate family/friend support as determined by psychological screening and/or interview;
- •Unable to maintain a stable psychotropic medication regimen in the next 12 months;
- •Pregnant or has plans to become pregnant in the next 12 months;
结局指标
主要结局
changes in the Montgomery-Asberg Depression Rating Scale from baseline to 9 months
时间窗: Baseline (preoperative),one month, 3 months, 6 months, 9 months
The score of the scale ranges from 0 to 60.
changes in the Hamilton Depression Scale(HAMD-17) score from baseline to 9 months
时间窗: Baseline (preoperative),one month, 3 months, 6 months, 9 months
The score of the scale ranges from 0 to 50.
次要结局
- changes in the brain activity(Baseline (preoperative),one month, 9 months)
- Chang in Pittsburgh Sleep Quality Index(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Changes in Hamilton Anxiety Scales(HAMA)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- World Health Organization Quality of Life-BREF(WHO-BREF)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Sheehan Disability Scale(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Young Mania Rating Scale (YMRS)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Global Assessment of Functioning Scale(GAF)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Changes in Neuropsychological measures(Scores of CANTAB tasks)(Baseline (preoperative),3 months, 9 months)
- Side Effects(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- Changes in Beck Depression Inventory(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
- the MOS item short from health survey (SF-36)(Baseline (preoperative),one month, 3 months, 6 months, 9 months)
研究者
Bomin Sun
Director of the Department of Functional Neurosurgery
Ruijin Hospital
研究点 (1)
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