DRKS00027867招募中未知
SleepLess - Imaging synaptic plasticity in therapeutic sleep deprivation for major depression - SleepLess
Forschungszentrum Jülich GmbH, Institut für Neurowissenschaften und Medizin (INM-2)0 个研究点目标入组 60 人开始时间: 2022年1月19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
- 60
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
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Age between 20 and 50
- •- Male or female
- •- Presentation of a written declaration of consent
- •- For women of childbearing age: a negative pregnancy test, and use of effective contraception for at least 3 months.
- •- Depressive disorder (ICD-10: F32.2 and F33.2)
- •- Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD).
排除标准
- •- BMI > 35
- •- Lack of a legally valid declaration of consent
- •- Not able to speak German
- •- Any medication with influence on the examination parameters
- •- Blood-thinning medication or known (diagnosed) coagulation disorders
- •- Chronic diseases: e.g. neurological, cardiopulmonary, endocrinological, renal, hepatic, psychiatric (except depressive disorder), autoimmunological diseases
- •- DSM-V Axis I disorder (lifetime) other than depressive disorder, such as schizophrenia, schizoaffective disorder, other non-bipolar mental disorders, bipolar disorder, primary anxiety disorder or obsessive-compulsive disorder, mental retardation, signs of impaired cognitive performance
- •- psychotic symptoms, suicidal intentions
- •- sleep disturbances in healthy subjects
- •- Shift and night work
- •- Occupational exposure to radiation
- •- Drug dependence
- •- Electrical implants for stimulation or therapy
- •- All metallic objects on or in the body (e.g. surgical screws, implants and/or osteosynthesis
- •and/or osteosynthesis material) for which there is no MRI compatibility
- •- Fixed braces or retainer wires
- •- Tattoos in the examined body region
- •- Intensive grinding work on metallic objects in the past month
- •- Complaints, e.g. back pain, which make it difficult to lie still for a longer period of time.
- •- Pregnancy, breastfeeding women
- •- Incapacitated persons, persons with limited legal capacity and persons in official or judicial custody.
- •- Any other condition which, in the opinion of the doctors conducting the study, makes the subject unsuitable (e.g. claustrophobia, non-compliance).
- •- Copper IUDs
- •- Hormonal IUDs with interaction in relation to MRI
- •- Excessive caffeine intake (regularly >500 mg caffeine or five cups of coffee per day).
- •- Excessive smoking (>15 cigarettes/day)
研究者
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