2024-515475-35-00招募中2 期
Glucocorticoid enhancement of food exposure therapy in Binge Eating Disorder
Universitaetsmedizin Goettingen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月23日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- decrease of food craving in response to real food 3-7 days after treatment
研究概览
简要总结
The central research question of this project is whether a combination of (food) exposure with response prevention (ERP) and cortisol is superior to ERP under placebo in terms of the reduction of craving for food in Binge Eating Disorder (BED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Trial phase
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with BED according to DSM-5
- •Male or female patients aged between 18 and 40 (the upper age limit was chosen to minimise potential confounding effects by hormonal changes related to menopause)
- •Written informed consent obtained according to international guidelines and local laws
- •Ability to understand the nature of the trial and the trial related procedures and to comply with them.
排除标准
- •systemic (i.v. or oral) glucocorticoid treatment within the last 3 months
- •known pheochromocytoma
- •Simultaneous participation in another interventional trial
- •Pregnant or breastfeeding females
- •current diagnosis of a psychotic, bipolar, or substance use disorder
- •severe somatic illness (e.g. cancer, cardiovascular disease, instable diabetes mellitus; blood pressure ≥ 160/100 mmHg at rest and/or current treatment of hypertensive crisis within last 6 months)
- •current or planned use of psychotropic medication (during the period of the study)
- •current or planned psychotherapy (during the period of the study)
- •known hypersensitivity to hydrocortisone
- •known hereditary galactose intolerance
- •known lactase deficiency
- •known glucose-galactose malabsorption
结局指标
主要结局
decrease of food craving in response to real food 3-7 days after treatment
decrease of food craving in response to real food 3-7 days after treatment
次要结局
- decrease in fear of loss of control over eating and arousal/distress in response to real food
- food craving in response to visual food cues
- amount of food intake
- trait level food craving 3-7 days after treatment and 1 month after treatment
- decrease in number of days and episodes of binge eating and overeating 1 month after treatment
- continuous decrease in food craving
- fear of loss of control over eating and arousal/distress during intervention sessions
研究者
Florian Walker
Scientific
Universitaetsmedizin Goettingen
研究点 (1)
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