NCT00636649已完成不适用
Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Night Eating Questionnaire
研究概览
简要总结
Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Age 18-70 years
- •Presence of NES
- •BMI 25-50
排除标准
- •History of schizophrenia or other psychoses
- •History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
- •Current major depressive disorder
- •Suicidal ideation
- •Psychotropic drugs in the past month
- •Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
- •Lack of benefit with SSRI treatment for NES
- •Serious or unstable medical illness
- •Allergy or hypersensitivity to escitalopram
- •Pregnant, breast-feeding, or planning pregnancy in the next six months.
研究组 & 干预措施
B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
A
Experimental
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Night Eating Questionnaire
时间窗: baseline, 12 weeks
The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.
次要结局
- Change in Three Factor Eating Questionnaire (TFEQ)(Baseline, 12 weeks)
- Change in Beck Depression Inventory II (BDI-II) Score(Baseline, 12 weeks)
- Change in Lipid Panel(Baseline,12 weeks)
- Change in Weight(Baseline, 12 week)
- Number of Participants Who Had a 50% Reduction in NEQ Scores(Week 12)
- Change in Coping Inventory for Stressful Situations (CISS)(Baseline, 12 weeks)
- Change in Glucose(Baseline, 12 Week)
- Change in Perceived Stress Scale (PSS)(12 weeks)
- Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2(12 weeks)
- Number of Participants Who no Longer Meet the NESHI Criteria(Week 12)
- Change in Beck Anxiety Inventory (BAI) Score(Baseline, 12 weeks)
研究者
研究点 (2)
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