EUCTR2007-005631-29-DK进行中(未招募)1 期
Cannabinoid CB1 receptor agonist treatmentin severe chronic anorexia nervosa
Center for Spiseforstyrrelse, Endokrinologisk Afdeling M, Odense Universitetshospital0 个研究点目标入组 22 人开始时间: 2008年3月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1Patients under treatment for AN.
- •2Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
- •3Patients admitted to Department of Endocrinology M or Psychiatric department P which are not expected to be discharged during the study period.
- •4Age over 18.
- •5Duration of the disease over 5 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
- •2Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
- •3Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
- •4Patients not attending to the weekly controls.
- •5If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
- •6Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
- •7Patients with known allergy to dronabinol or sesam oil.
- •8Fertile, menstruating women not using safe contraception*.
- •9Pregnancy.
- •* - Patients with chronic AN have per definition amenorrhea and seldom vita sexualis.
研究者
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