DRKS00013764招募中未知
Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC) - DepressionDC
udwig-Maximilians-Universität München0 个研究点目标入组 152 人开始时间: 2018年4月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Men and women 18-65 years of age.
- •- Primary DSM-5 diagnosis of Major Depression as assessed by the Structured Clinical Interview for DSM-5 Axis I Disorders, Research Version (SCID-5-RV) with a single or recurrent episode with the additional requirements of a current episode with a duration of =4 weeks.
- •- Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of =2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
- •- Total HDRS-21 =15 at the screening visit.
- •- The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 2 on the ATHF) in the current episode.
- •- Patient is taking a SSRI of adequate dose and =4 weeks (defined as a minimum level of 2 on the ATHF) in the current episode.
- •- Capable and willing to provide informed consent.
- •- Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e <. 2 years post-menopausal)
排除标准
- •- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
- •- Acute risk for suicide (MADRS, item 10 score of >4 or as assessed by the C-SSRS, agree to item 4 and/or to item 5).
- •- High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode (each attempt with an ATHF score of >3).
- •- Treatment with electroconvulsive therapy in the present episode.
- •- Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
- •- Any other relevant psychiatric axis-I- and/or axis-II-disorder.
- •- Any relevant instable medical condition.
- •- History of treatment with tDCS for any disorder.
- •- Pregnancy.
研究者
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