Hormonal Factors in the Treatment of Anorexia Nervosa

描述(由申请人提供)：神经性厌食症是一种以体重严重减轻为特征的疾病，发病率增加。这种疾病与多种严重的医学后果有关，导致精神障碍中死亡率最高。鉴于这种疾病在青少年和年轻人中的显著发病率，它是一个重要的公共卫生问题。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范例。精神共病，包括焦虑和抑郁，在神经性厌食症患者中很常见。研究还表明，共病焦虑和抑郁症状通常与进食障碍的持久性和结局有关，严重抑郁和更高水平的焦虑预示着不良的进食障碍结局。我们已经证明，一种以前未被认识到的内分泌缺陷，低水平的睾酮激素在神经性厌食症女性中很常见，并与疾病的严重程度直接相关。在初步数据中，生理性睾丸素替代与饮食紊乱清单-2得分的降低、BMI的增加和精神疾病并存的减少有关。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考试成绩的改善和核心神经性厌食症症状的整体改善。这项研究的总体目标是确定小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实现生理性睾丸素的给药。患者将随机接受睾丸素或安慰剂贴片治疗。主要的终点将是BMI，饮食失调问卷-2分，抑郁和焦虑分。在这一人群中证明睾丸激素的有效性将代表着一种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.