NCT02253355Unknown早期 1 期
PINS Stimulator System for Patients With Treatment Resistant Depression
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 主要终点
- Changes in the Hamilton Depression Rating Scale-17
研究概览
简要总结
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged ages 20-70 years
- •Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
- •First episode onset before age 45
- •Current episode > 12 months duration
- •In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
- •SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria
- •Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%
排除标准
- •Patients with hearing impairment
- •Failures of important organs and in severe conditions
- •Be reluctant or disabled to receive neuropsychological assessments;
- •Participate in other clinical trial
- •Has a life expectancy of < 1 year
- •The investigator and/or enrollment review committee, would preclude participation in the study
结局指标
主要结局
Changes in the Hamilton Depression Rating Scale-17
时间窗: 1, 3, 6 and 12 months of stimulation
次要结局
- The incidence of all adverse events(1, 3, 6 and 12 months of stimulation)
研究者
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