A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Working memory ability evaluation(N-Back tast)
研究概览
简要总结
This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.
详细描述
During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder
- •CGI severity (severity of Illness) score of 3 or higher
- •Patients receiving medication for depression at the time of study participation
- •Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires
排除标准
- •History of clinically significant medical neurological disease or history of head injury
- •In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
- •Severe suicidal risk or psychotic symptoms determined by the clinician
- •In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
- •Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
- •Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial
- •Pregnant women
- •Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
研究组 & 干预措施
High real stimulation group
2mA tDCS stimulation daily (42 times) for 6 weeks
干预措施: Transcranial direct current stimulation_High real (Device)
Low real stimulation group
1mA tDCS stimulation daily (42 times) for 6 weeks
干预措施: Transcranial direct current stimulation_Low real (Device)
Sham stimulation group
sham stimulation daily (42 times) for 6 weeks
干预措施: Transcranial direct current stimulation_Sham (Device)
结局指标
主要结局
Working memory ability evaluation(N-Back tast)
时间窗: Change from Baseline Working memory ability evaluation at 6 weeks.
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.
次要结局
- Hamilton Rating Scale(Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks)
- Hamilton Anxiety Rating Scale(Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks)
研究者
ji hyun baek, MD, Ph.D
Principal Investigator
Samsung Medical Center