Atypical Antipsychotic Medication in Anorexia Nervosa

描述(申请人提供)：神经性厌食症(AN)是一种严重的疾病，具有相当高的发病率和死亡率。虽然该领域已经达成共识，体重恢复是治疗的重点，但对于AN患者，没有特定的治疗方法得到明确的经验支持。NIMH已将AN确定为一种需要治疗研究倡议的疾病。 这份R21精神健康干预研究探索性/发展补助金的申请描述了一项建议，即为使用非典型抗精神病药物的体重不足的门诊患者开发和试验一种创新的治疗方法。 该项目建议在哥伦比亚大学和多伦多大学两个地点进行合作研究，这两个大学都以研究和治疗饮食失调而闻名。该项目将正式评估非典型抗精神病药物奥氮平和阿立哌唑的耐受性和可接受性，并对疗效进行总体评估。此外，它还将评估服药依从性的贡献者，并开发干预措施，以减少患者不愿服用与体重增加相关的药物。 该项目的最初一年将用于比较奥氮平和阿立哌唑，奥氮平是一种据报道在AN中有希望的药物，阿立哌唑是另一种非典型的抗精神病药物，没有明显的体重增加作为副作用。在该项目的这一阶段，将进行一项开放的随机对照试验，以开发关于益处、耐受性、可接受性、安全性和适当剂量的信息。这些数据将用于选择奥氮平或阿立哌唑进行进一步评估。此外，该项目的早期阶段将包括制定治疗战略，以提高新的、潜在有用的药物的可接受性和依从性。 在该项目的第二年和第三年，将对选定的药物进行安慰剂对照的试点研究，以获得有关一般疗效的受控数据，并估计效果大小，为更大规模和更明确的临床试验做准备。

DESCRIPTION (provided by applicant): Anorexia Nervosa (AN) is a serious disorder with substantial morbidity and mortality. While there is agreement in the field that weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. The NIMH has identified AN as an illness in need of treatment research initiatives. This application for an R21 exploratory/development grant for mental health intervention research describes a proposal to develop and pilot an innovative treatment for underweight outpatients with AN using atypical antipsychotic medication. This project proposes a collaborative study at two sites, Columbia University and The University of Toronto, both well known for the study and treatment of eating disorders. The project will formally evaluate the tolerability and acceptability, and make a general estimate regarding efficacy, of the atypical antipsychotic agents olanzapine and aripiprazole. Additionally, it will assess contributors to medication compliance and develop interventions to decrease patients' reluctance to take a medication associated with weight gain. The initial year of the project will be used to compare olanzapine, a medication reported to have promise in AN, with aripiprazole, another atypical antipsychotic medication without significant weight gain as a side effect. During this phase of the project, an open randomized comparison trial will be conducted in order to develop information regarding benefits, tolerability, acceptability, safety, and appropriate dosage. These data will be used to select either olanzapine or aripiprazole for further evaluation. Additionally, the early phase of the project will include development of treatment strategies to improve acceptability and compliance for new, potentially useful medications. In the second and third years of the project, a placebo-controlled pilot study of the selected medication will be conducted to obtain controlled data about general efficacy and to estimate effect size in preparation for a larger and more definitive clinical trial.