Hormonal Factors in the Treatment of Anorexia Nervosa

治疗神经性厌食症的激素因素

基本信息

批准号：
8401158
负责人：
ANNE KLIBANSKI
金额：
$ 40.42万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-03-15 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8401158
关键词：
Adolescent Adverse effects Anorexia Nervosa Anxiety Body Composition Body Weight decreased Body mass index Bulimia Comorbidity Data Disease Disease Outcome Dose Eating Disorders Endocrine Equipment and supply inventories Evaluation Fatty acid glycerol esters Goals Hamilton Rating Scale for Depression Hormonal Hormones Incidence Investigation Lead Measures Medical Mental Depression Mental disorders Metabolic Morbidity - disease rate Neurosecretory Systems Normal Range Outcome Patients Perception Pharmaceutical Preparations Physiological Placebos Population Preparation Psychiatric therapeutic procedure Public Health Randomized Resistance Severities Severity of illness Shapes Symptoms System Testing Testosterone Thinness Time Treatment outcome Visceral Weight Weight Gain Woman abdominal fat base body dissatisfaction depressive symptoms hormone deficiency hormone therapy improved mortality muscle form novel novel strategies novel therapeutics public health relevance subcutaneous treatment duration treatment strategy young adult

项目摘要

DESCRIPTION (provided by applicant): Anorexia nervosa is a disease characterized by severe loss of weight with increased morbidity. The disorder is associated with multiple severe medical consequences, resulting in the highest mortality rate among psychiatric disorders. The disorder represents an important public health concern, given its significant incidence among adolescents and young adults. Treatment strategies used to date have been largely ineffective and there is a critical need to develop and explore novel therapeutic paradigms. Psychiatric co-morbidities including anxiety and depressions are common in patients with anorexia nervosa. Studies have also shown that co- morbid anxiety and depressive symptoms are often associated with eating disorder persistence and outcome, and, that severe depression and higher levels of anxiety predict poor eating disorder outcome. We have shown that a previously unrecognized endocrine deficiency, low levels of the hormone testosterone is common in women with anorexia nervosa and directly related to disease severity. In preliminary data, physiologic testosterone replacement is associated with a reduction in Eating Disorders Inventory-2 scores, and increase in BMI and decreases in psychiatric co-morbidities. We hypothesize that testosterone is an effective means to reduce to major co-morbidities, depression and anxiety and in doing so will lead to an improvement in Eating Disorders Examination scores and overall improvement in core anorexia nervosa symptoms. The overall goal of this study is to determine the efficacy of low-dose testosterone replacement in the treatment of anorexia nervosa. This will be accomplished by physiologic testosterone administration through a novel transdermal delivery system. Patients will be randomized to either testosterone or a placebo patch. The main endpoints will be BMI, Eating Disorders Inventory-2 scores, depression and anxiety scores. The demonstration of testosterone efficacy in this population would represent a novel strategy to treating this disorder.

描述（由申请人提供）：神经性厌食症是一种以体重严重减轻且发病率增加为特征的疾病。该疾病与多种严重的医疗后果有关，是精神疾病中死亡率最高的疾病。鉴于该疾病在青少年和年轻人中的发病率很高，因此它是一个重要的公共卫生问题。迄今为止使用的治疗策略基本上无效，迫切需要开发和探索新的治疗范例。包括焦虑和抑郁在内的精神共病在神经性厌食症患者中很常见。研究还表明，共病的焦虑和抑郁症状通常与饮食失调的持续性和结果相关，并且严重的抑郁和较高水平的焦虑预示着饮食失调的不良结果。我们已经证明，以前未被认识到的内分泌缺陷、睾酮激素水平低在患有神经性厌食症的女性中很常见，并且与疾病的严重程度直接相关。初步数据显示，生理性睾酮替代与饮食失调量表 2 评分的降低、BMI 的增加以及精神并发症的减少有关。我们假设睾酮是减少主要并发症、抑郁和焦虑的有效手段，这样做将导致饮食失调检查分数的改善和神经性厌食症核心症状的整体改善。本研究的总体目标是确定低剂量睾酮替代治疗神经性厌食症的疗效。这将通过一种新型的透皮给药系统进行生理性睾酮给药来实现。患者将被随机分配使用睾酮贴剂或安慰剂贴剂。主要终点是 BMI、饮食失调量表 2 评分、抑郁和焦虑评分。睾酮在这一人群中的疗效的证明将代表一种治疗这种疾病的新策略。