A 10-week Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Omega-3 Fatty Acids Oral Capsules Compared With Placebo in the Treatment of Anorexia Nervosa
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline
研究概览
简要总结
The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.
详细描述
10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. Patients will be randomly assigned to blinded study treatment. Double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. Some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. In such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. Patient will be treated as inpatients during 10 weeks of the study. The study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with DSM-IV and ICD-10 diagnosis of anorexia nervosa.BMI below 5 percentile and EAT-26 score > 30 is required at both screening and randomization.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anorexia nervosa (DSM IV,ICD-10)
- •Age 12-19
- •Written informed consent given by patient and his parents
排除标准
- •Lack of informed consent
结局指标
主要结局
Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline
时间窗: day 70th
The primary objective of this study is to compare the efficacy of EPA fatty acids with that of placebo as add-on treatment for inpatients with anorexia nervosa, as assessed by the change from baseline to day 70 in BMI (body mass index)
次要结局
- reducing EAT -26(day 70th)
- changes in CGI(day 70th)
- change in HDRS(day 70 th)
- changes in BDI(day 70th)
- changes in YBOCS(day 70th)
- adverse events(70 days time)
- clinical laboratory tests(day 70 th)
研究者
Agnieszka Piróg-Balcerzak
MD, psychiatrist
Institute of Psychiatry and Neurology, Warsaw
