Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from Baseline in Calgary Depression Scale for Schizophrenia
研究概览
简要总结
Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Able to give informed consent
- •Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5
- •Has a score ≥ 7 on Calgary depression scale for schizophrenia
- •The principal psychotropic agents are not changed within one month of the first session of rTMS
排除标准
- •DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months
- •Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE < 15)
- •With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.)
- •With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)
- •Pregnant, or has a pregnancy plan within 3 months
- •With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion
- •Received rTMS or iTBS treatment within 3 months
- •Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
研究组 & 干预措施
conventional rTMS
target: left DLPFC
protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
iTBS
target: left DLPFC
protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
sham rTMS
target: left DLPFC
sham probe, the same protocol as active conventional rTMS
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
sham iTBS
target: left DLPFC
sham probe, the same protocol as active iTBS
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change from Baseline in Calgary Depression Scale for Schizophrenia
时间窗: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
A 9-item scale developed for detecting major depressive episode for schizophrenia patients. Total score ranges from 0 to 27. Lower score indicates less depressive symptoms. A cut-off of 7 points yields to sensitivity of 85% and specificity of 82%.
次要结局
- Change from Baseline in Negative symptoms assessment 16(baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85)
- Change from Baseline in Clinical global impression(baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85)
- Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale(baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85)
- Change from Baseline in Positive and Negative syndrome scale(baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85)