A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.
研究概览
简要总结
The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations.
The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.
详细描述
Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.
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, Investigator)
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
- •Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations.
- •Use of at least 400mg/day of clozapine
- •Men and women from 18 to 65 years old
- •Fertile women must be using adequate contraceptive method
- •BPRS score of at least 27
排除标准
- •Suicide risk
- •Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head
- •Diagnose of substance abuse/dependance
- •Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- •Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.
结局指标
主要结局
Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.
时间窗: 2 years
次要结局
- The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.(2 years)