Melatonin Treatment for Night-Eating Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score
研究概览
简要总结
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin treatment on weight, metabolic parameters and sleep parameters in individuals with NES.
详细描述
Night Eating Syndrome (NES) is a unique disorder characterized by a delayed pattern of food intake in which recurrent episodes of food consumption occurs after the evening meal and/or during nocturnal awakenings. Diagnostic criteria for NES include: (1) recurrent episodes of night eating, as manifested by eating after awakening from sleep or by excessive food consumption following the evening meal, (2) awareness of those eating episodes, and (3) significant distress or impairment caused by the disorder. Exclusion criteria are binge-eating disorder or another mental disorder, as well as medical disorders or medications that might better explain the disordered eating pattern. NES is also more common among patients with insomnia, eating disorders, and other psychiatric disorders. 100 participants with night eating syndrome will be recruited from the general population. They will be randomized to either a commercially available rapid-release formulation of melatonin (5 mg) or matching placebo capsules, that will be administered once a day for a total of 8 weeks. Participants will attend a screening appointment, a baseline assessment and additional research assessment visits every other week for the 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 65 years of age
- •English speaking
- •Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES)
排除标准
- •Unable to provide informed consent
- •Presence of alcohol/substance dependence
- •Presence of other eating disorders such as Binge Eating Disorder, Anorexia Nervosa.
- •Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
- •Women who are pregnant or breastfeeding
- •Allergy or hypersensitivity to melatonin
研究组 & 干预措施
Melatonin
A commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks
干预措施: Melatonin (Dietary Supplement)
Placebo
Matching placebo capsules to be administered once a day for a total of 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score
时间窗: 8 weeks
Change in total score for the Night Eating Symptom Scale (NESS) from baseline to endpoint. Scores range from 0-52. Lower scores are better than higher scores.
次要结局
- Change in body weight in kilograms during study duration.(8 weeks)
- Change in body mass index (BMI) during study duration(8 weeks)
- Change in waist circumference in centimeters during study duration.(8 weeks)
研究者
Cenk Tek
Associate Professor of Psychiatry
Yale University
