Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- cognitive functioning assessed on RBANS
研究概览
简要总结
The investigators investigated the effects of high frequency (10Hz) repetitive transcranial magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with psychiatric disorders
详细描述
OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders
METHODS:
- Clinical Trial：The study consists of 4 weeks of treatment.
- Assess Procedures:
2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS) or DSM-IV for depression, and repeatable battery for the assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks.
2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Schizophrenia Patients:
- •Diagnosis of schizophrenia by two senior psychiatrists
- •Between 18 and 60 years and Han Chinese
- •Duration of symptoms at least 12 months
- •With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24)
- •For Major Depressive Disorder Patients:
- •Diagnosis of Major depressive disorder by two senior psychiatrists
- •Between 18 and 60 years and Han Chinese
- •Duration of symptoms at least 12 months
排除标准
- •Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
- •Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
- •Severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
- •Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
- •Education level less than 5 years by subject report
- •Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
- •Subjects who suffered from alcohol or illegal drug abuse/dependence
结局指标
主要结局
cognitive functioning assessed on RBANS
时间窗: 4 weeks
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a test for identifying and characterizing abnormal cognitive decline in the elders and examining neuropsychological disorders for younger adults. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional, Language, Attention and Delayed Memory. Each of the five index is based on two subtests except Delayed memory index consisting of four subtests. The score from each index is scaled by the age group with the scaled score mean to be 100 and standard deviation equals to 15, then the total RBANS scored is summed up of these indexes with the same normal mean and standard deviation. The lower the RBANS score the patient receives, the grave cognitive declination appears.
symptoms assessed on PANSS
时间窗: 4 weeks
The Positive and Negative Syndrome Scale is often shorted as PANSS. It is a well-characterized and well-applied measurement instrument that measures positive and negative syndromes, their differential and general severity of illness. The items on the PANSS are defined with increasing levels from 1 to 7, the greater the value appears, the severe the level is: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. The PANSS score is finalized by summation of ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.
major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
时间窗: 4 weeks
The classification of major depressive disorder has been updated in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorder (DSM-V). It is defined by the lifetime absence of mania and hypomania, as well as one or more major depressive episodes. DSM description includes the diagnostic classification, the diagnostic criteria sets and the descriptive text. The diagnostic classification represents the official list of mental disorder with diagnostic codes that used by all U.S. health care professionals. The diagnostic criteria, specifically, the criteria for major depressive disorder consists: five or more out of nine related symptoms, symptoms cause significant distress or impairment, episode has not attribute to any substance or medical condition, the absent of psychotic disorder, the absent of any manic or hypomanic episode. Last but not the least, the descriptive text provides information like diagnostic features, diagnostic measures and functional consequences.
次要结局
- Side effect assessed on UKU(4 weeks)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital