A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.
详细描述
Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bipolar I or II patients, currently in a depression episode
- •Patient must have failed at least 2 medication
- •Score of 21-item Hamilton Rating Scale for Depression (HAM-D)
排除标准
- •Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
- •Substantial risk of suicide during the screening period that requires inpatient care
- •Presence of psychosis
- •Dual diagnosis of other primary, currently clinically significant severe mental disorders
- •History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
- •History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
- •Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
- •Patients who are pregnant or intend to become pregnant during the study period
- •Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
- •Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
- •Patient's Motor Threshold for TMS cannot be detected
- •Significant side effects which are intolerable during the screening or any later stage of the trial
- •Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks
研究组 & 干预措施
rTMS treatment
Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim
干预措施: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. (Device)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 5 weeks
Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.
次要结局
- Inventory of Depressive Symptomatology(5 weeks)