Estrogen replacement therapy (ERT) for treatment of adolescent anorexia nervosa – An open label study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q
研究概览
简要总结
The present project is a pilot study that aim to test the efficacy and feasibility of estrogen replacement therapy on psychological and physiological symptoms in girls with anorexia nervosa. Hence, if this pilot study shows results that the estrogen replacement treatment is feasible and the included patients show an improvement in anorectic symptoms, we will test this treatment in a full-scale randomized placebo-controlled trial. The pilot study will be performed within the health region of Northern Norway, UNN-HF. The drug that will be tested in the present study is already on the market and used for other purposes. Thus, the implementation of estrogen replacement therapy in clinical practice can therefore easily be performed and will provide options for improved treatment for patients with anorexia. The project fit the scope of the call that define clinical research and translational research as aims.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with anorexia nervosa, and anorexia with concomitant anxiety and depression will be included.
排除标准
- •One or more contra indices for use of hormonal contraceptives, hereditary predisposition for venous or arterial thrombosis, any previous unexplained vaginal bleeding, diagnosed or susceptible diabetes mellitus, any cerebrovascular disease, any type of heart failure, any neurological disease or structural brain damage, any past or present episodes of psychosis or mania, any current use of antipsychotic medication, diagnoses of mental retardation (F70-F79), pregnancy, past or present substance abuse.
结局指标
主要结局
Anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q
Anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q
次要结局
- Cortisol, ghrelin, T3, T4 levels, weight gain, cognitive performance (WCST, CVLT II), and Beck Youth Inventory scores
研究者
Klinisk Forskningsavdeling
Scientific
Universitetssykehuset Nord-Norge HF