Hormonal Factors in the Treatment of Anorexia Nervosa

描述（由申请方提供）：神经性厌食症是一种以体重严重减轻伴发病率增加为特征的疾病。这种疾病与多种严重的医疗后果有关，导致精神疾病中死亡率最高。这种疾病是一个重要的公共卫生问题，因为它在青少年和年轻人中的发病率很高。迄今为止使用的治疗策略在很大程度上是无效的，迫切需要开发和探索新的治疗模式。神经性厌食症患者常见精神共病，包括焦虑和抑郁。研究还表明，共病焦虑和抑郁症状往往与饮食失调的持续性和结果有关，严重的抑郁和较高水平的焦虑预示着不良的饮食失调结果。我们已经证明，一个以前未被认识到的内分泌缺陷，低水平的激素睾酮是常见的女性神经性厌食症，并直接关系到疾病的严重程度。在初步数据中，生理性睾酮替代与进食障碍量表-2评分降低、BMI增加和精神共病减少相关。我们假设睾酮是减少主要合并症、抑郁和焦虑的有效手段，这样做将导致进食障碍检查评分的改善和核心神经性厌食症症状的整体改善。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。这将通过一种新的经皮给药系统的生理睾酮管理。患者将随机接受睾酮或安慰剂贴剂。主要终点为BMI、进食障碍量表-2评分、抑郁和焦虑评分。在这一人群中证明睾酮的疗效将代表治疗这种疾病的新策略。

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.