Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wechsler Memory Scale
研究概览
简要总结
The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-65 years old, regardless of gender;
- •Meet DSM-V diagnostic criteria for depression or bipolar disorder;
- •Duration of stable period ≥ 3 months;
- •Young Mania Rating Scale (YMRS) ≤ 6 points;
- •Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
- •The score of cognitive defects questionnaire (PDQ) ≥ 17;
- •Han nationality, right-handed;
- •More than 9 years of education.
排除标准
- •History of severe somatic or brain organic diseases and craniocerebral trauma;
- •Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
- •Those who do not cooperate or cannot effectively complete the experiment;
- •Drug, alcohol or other psychoactive substance abusers;
- •Pregnant, lactating or planned pregnancy.
结局指标
主要结局
Wechsler Memory Scale
时间窗: 0-8 weeks
The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.
次要结局
未报告次要终点
研究者
Hu ShaoHua
Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Zhejiang University