NCT00760695已完成3 期
Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.
Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo
Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.
详细描述
The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on:
- Weight
- Eating Disorder Inventory (EDI) scale
- Motor and inner restlessness (estimated by accelerometry)
- Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under treatment for AN.
- •Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
- •Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.
- •Duration of the disease over 5 years.
排除标准
- •Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
- •Patients 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.
- •Patients 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).
- •Patients not attending to the weekly controls.
- •If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
- •Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
- •Patients with known allergy to dronabinol or sesame oil.
- •Fertile, menstruating women not using safe contraception.
- •Pregnancy.
研究组 & 干预措施
A
Active Comparator
the patients in this arm are receiving 2,5 mg dronabinol twice daily
干预措施: dronabinol (Drug)
B
Placebo Comparator
the patients in this arm are receiving 2,5 mg placebo twice daily
干预措施: placebo (Drug)
结局指标
主要结局
Weight gain
时间窗: 4 weeks
次要结局
- Eating Disorder Inventory (EDI) scale(4 weeks)
- Motor and inner restlessness (estimated by accelerometry)(4 weeks)
- Endocrine parameters(4 weeks)
研究者
Tine Hylle
for Alin Andries
Odense University Hospital
研究点 (1)
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