The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of body weight
研究概览
简要总结
cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals 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, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.
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
- •BMI over 24
- •Accepting antipsychotics stable treatment for more 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
结局指标
主要结局
Change of body weight
时间窗: from baseline to 6 weeks
the change of participants weight
Change of body mass index
时间窗: from baseline to 6 weeks
the change of participants BMI
次要结局
- Barrat impulsiveness scale(from baseline to 6 weeks)
- Positive and Negative syndrome rating scale(from baseline to 6 weeks)
- Three Factor Eating Questionnaire(from baseline to 6 weeks)
- Food picture stimulation Event-related potentials(from baseline to 6 weeks)
- Self-Control Scale(from baseline to 6 weeks)
研究者
Renrong Wu
Professor
Central South University