Brain Imaging and Treatment Studies of the Night Eating Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Symptoms of NES
研究概览
简要总结
The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.
详细描述
This proposal explores the implications of our two recent major discoveries: the striking efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) sertraline in the control of the Night Eating Syndrome (NES) and the unprecedented elevation in the level of serotonin transporter (SERT) binding in the midbrain of persons with NES. Our overall theory is that NES is associated with a syndrome-specific increase in SERT derived from a genetic vulnerability which is affected by life stress. This increased SERT activity produces a fall in post-synaptic serotonin levels. The investigators hypothesize that these decreased serotonin levels result in a significant phase delay in circadian food intake manifested by evening hyperphagia, nighttime ingestions and morning anorexia. SSRIs that block this increased SERT activity increase synaptic serotonin levels and restore the circadian rhythm of food intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women suffering from NES
- •ages 18 to 70 years
- •BMI greater than 18.5 kg/m2
排除标准
- •Children or adolescents <18 years
- •persons older than 70
- •patients with diabetes mellitus
- •thyroid disease and other endocrine and metabolic disorders
- •use within the past month of any psychotropic medication, oral steroids, diuretics or hypnotics
- •current anorexia nervosa or bulimia nervosa
- •participation in an organized weight reduction program
- •use of antiobesity medication
- •an occupation that involves night shifts or other unusual time requirements -Major Depressive Disorder (judged severe)
- •Bipolar Disorder
- •suicidal risk
- •current or past psychosis
- •substance use or abuse disorder within the past 6 months
研究组 & 干预措施
Night Eaters
Subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test will also be administered no more than 48 hours before SPECT-CT imaging and the beginning of escitalopram oxalate (Lexapro) treatment. Escitalopram oxalate (Lexapro) open-label treatment will last 12 weeks. Dosing will start at 10 mg and increase to 20 mg per day flexibly. Treatment will be discontinued starting at 12 weeks under the supervision of our study physician.
干预措施: escitalopram oxalate (Drug)
结局指标
主要结局
Change in Symptoms of NES
时间窗: 12 weeks
Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit.
次要结局
- Nocturnal Ingestions(12 weeks)
- Night Eating Symptoms(12 weeks)
研究者
Kelly Allison
Assistant Professor
University of Pennsylvania