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临床试验/NCT01761942
NCT01761942Unknown2 期

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

Institute of Psychiatry and Neurology, Warsaw2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月1日最近更新:
适应症

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

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

发起方
Institute of Psychiatry and Neurology, Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Agnieszka Piróg-Balcerzak

MD, psychiatrist

Institute of Psychiatry and Neurology, Warsaw

研究点 (2)

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