Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale（MADRS）
研究概览
简要总结
The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-28 years old, regardless of gender;
- •Meet DSM-V diagnostic criteria for bipolar depressive episodes;
- •Young Mania Rating Scale (YMRS) ≤ 6 points;
- •MARDS:12-30 points.
- •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.
- •Severe suicidal ideation and behavior
- •ECT or rTMS treatment was performed within six months
研究组 & 干预措施
Sham Repetitive Transcranial magnetic stimulation
干预措施: Sham Repetitive Transcranial magnetic stimulation (Device)
Repetitive Transcranial magnetic stimulation
干预措施: Repetitive Transcranial magnetic stimulation (Device)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale（MADRS）
时间窗: 0-8 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. The scale can be used to score at any time interval.
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