The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- BMI
研究概览
简要总结
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
详细描述
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with schizophrenia in accordance with DSM-5
- •The course of the disease less then 2 years
- •Accepting antipsychotics treatment for less then 2 months
排除标准
- •Diagnosed with other mental disease in accordance with DSM-5
- •Comorbid with other severe physiological disease
- •Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
- •Drug or alcohol abuse
- •Pregnant or lactating Contraindication to rTMS
研究组 & 干预措施
cTBS stimulation
The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
干预措施: transcranial magnetic stimulation (Device)
Sham stimulation
The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
干预措施: sham stimulation (Device)
结局指标
主要结局
BMI
时间窗: Change from Baseline to 6days and 36days
body mass index
The positive and negative syndrome scale
时间窗: Change from Baseline to 6days and 36days
min score 30, max score 210. The higher score means more severe symptoms.
Three-Factor Eating Questionnaire
时间窗: Change from Baseline to 6days and 36days
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
MCCB
时间窗: Change from Baseline to 6days and 36days
The MATRICS™ Consensus Cognitive Battery
次要结局
- Triglyceride(Change from Baseline to 6days and 36days)
- High Density Lipoprotein(Change from Baseline to 6days and 36days)
- Total Cholesterol(Change from Baseline to 6days and 36days)
- fasting glucose(Change from Baseline to 6days and 36days)
- Low Density Lipoprotein(Change from Baseline to 6days and 36days)
- Resting EEG(Change from Baseline to 6days and 36days)
研究者
Renrong Wu
Professor
Central South University