Therapeutic Brain Stimulation for Refractory Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep brain stimulation (DBS) in patients with treatment resistant depression (TRD).
The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to improvements in TRD patients, and specific neuroimaging biomarkers will correlate with response to DBS; the functional recovery will be enhanced with concurrent cognitive behavioural therapy (CBT).
详细描述
The aim is to collect data on prediction, optimization and augmentation of DBS for TRD and develop tools for DBS surgery. It is a biological pilot study designed to provide informative data for future work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •age 20-70
- •diagnosis of major depressive (MDD)or bipolar disorder(BP)determined independently by 2 study psychiatrists
- •current major depressive episode of >1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, CBT, or electroconvulsive treatment despite adequate dosage, duration and compliance)
- •minimum score of 20 (out of 52) on the 17 item Hamilton Depression Rating Scale (HDRS)
- •resident of Alberta, Canada, covered by Alberta Health
排除标准
- •other Axis I psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months
- •cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for DBS surgery (e.g. cardiac pacemaker/defibrillator)
研究组 & 干预措施
Long Pulse Width
deep brain stimulation with short & long pulse width
干预措施: deep brain stimulation with short & long pulse width (Device)
Short Pulse Width
deep brain stimulation with short & long pulse width
干预措施: deep brain stimulation with short & long pulse width (Device)
结局指标
主要结局
Change in Hamilton Depression Rating Scale
时间窗: 6 and 12 months post-operatively
change in HDRS from baseline before surgery: rates of remission (defined as an HDRS score \<8 at 6 and 12 months) and response (defined as \>50% reduction in HDRS)
次要结局
- Change from baseline on Illness Density Index, Montgomery-Asberg Depression Rating Scale and Hamilton Anxiety Scale, Positive and Negative Affect Scale, Clinical Global Impression of Change, GAF< SAs, NAS, Q-LES-Q-SF & neuropsychological tests(6 and 12 months post operatively)
- Post Cognitive Behavioural Therapy Scores(15 months post operatively)
研究者
Zelma Kiss
Associate Professor, Neurosurgery; Director Clinician Investigator Program
University of Calgary