DRKS00029367尚未招募未知
oradrenergic control of neurobehavior in human binge-eating disorder and obesity - NOBEAD
Forschungsbereich Verhaltensmedizin, Integriertes Forschungs- und Behandlungszentrum AdipositasErkrankungen, Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsmedizin Leipzig0 个研究点目标入组 80 人开始时间: 2022年6月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
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
- •1. The OB+BED sample will consist of individuals with BED according to DSM-5 as determined through the Eating Disorder Examination interview and BMI 30.0-45.0 kg/m2.
- •2. The OB-BED sample will consist of individuals without BED and with BMI 30.0-45.0 kg/m2.
- •3. The NW sample will include individuals without BED and with BMI 18.5-25.0 kg/m2.
- •Additional general inclusion criteria are:
- •4. Informed consent
- •5. Sufficient German language skills and a feasible commute to the medical campus of Leipzig University
排除标准
- •1. Serious somatic conditions (e.g., neurological disorders, stroke, head injury, manifest diabetes, severe hypertension)
- •2. Serious mental disorders (e.g., psychotic disorder, suicidality, substance use disorder, ADHD, depression, anxiety disorder), as determined by the clinical interview Mini-DIPS, and developmental or intellectual disability
- •3. Medication acting on the central nervous system; use of anorexic medication or other interventions for weight loss in the past 6 months
- •4. Ongoing psychotherapy; past or present history of alcohol misuse or the use of illegal drugs (ensured by urine screening)
- •5. Pregnancy or breast-feeding females, or persons being held by judicial or official order, or other contraindications for the use of radiotracers according to the radiation protection legislation; Women of child bearing potential will be interviewed regarding a potential pregnancy and in addition urine pregnancy testing will be performed prior to the administration of [11C]MRB using a standard kit.
- •6. MRI contraindications such as ferromagnetism (e.g., pacemaker, drug-delivery systems), or claustrophobia; there will be no application of contrast media
- •7. To avoid interference of ethanol with the radiopharmaceutical, the use of any alcoholic beverages and/or other compounds that include alcohol is prohibited for at least 48 hours prior to PET investigation. The use of medical drugs which inhibit the reboxetine-degrading liver enzyme (such as ketoconazol or fluvoxamine), which interact with reboxetine (e.g., monoamine-oxidase inhibitors or lorazepam), or which may displace [11C]MRB from the binding site (such as atomoxetine or nisoxetine) is excluded as well.
研究者
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