DOUBLE BLIND TRIAL OF QUETIAPINE(SEROQUEL) IN ANOREXIA NERVOSA

喹硫平（思瑞康）治疗神经性厌食症的双盲试验

• 批准号: 7606578
• 负责人: WALTER KAYE
• 金额: $ 0.19万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606578
• 关键词: Adverse effects; Anorexia Nervosa; Anxiety; Binge Eating; Computer Retrieval of Information on Scientific Projects Database; DSM-IV; Dose; Double-Blind Method; Eating Disorders; Equipment and supply inventories; Functional disorder; Funding; Grant; Institution; Interview; Medication Management; Mental Depression; Outcome; Pathway interactions; Patients; Pilot Projects; Placebos; Research; Research Personnel; Resources; Safety; Seroquel; Serotonin; Source; Symptoms; United States National Institutes of Health; Week; Weight Gain; double-blind placebo controlled trial; purge; quetiapine; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Several lines of evidence suggest that disturbances of 5-HT and DA pathways contribute to core eating disorder pathophysiology. This pilot study seeks to determine the most effective dose and side effect profile and safety/tolerability. If these objectives are met, a larger double-blind, placebo-controlled trial may be necessary to demonstrate the primary and secondary objectives as well as to determine whether response is specific to AN subtype. This study may be adequately powered to detect a difference in core eating disorder symptoms. Primary Outcomes: Primarily we will seek to show that Quetiapine is superior to placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorders Inventory-2. Secondary Outcomes: We will seek to show that Quetiapine is superior to placebo in reducing anxiety (STAI), depression (Hamilton DI), obsessionality (YBOCS), or weight gain (BMI) in patients with DSM-IV AN (either restricting or binge-eating purging types) when administered for 8 weeks. Additionally, we will seek to show that Quetiapine is superior to placebo at reducing positive and negative symptoms on the Positive and Negative Symptom Scale (PANSS). Finally, we will track Quetiapine response, course and outcome using both the Pittsburgh Quetiapine Medication Management Assessment and interview.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 多项证据表明，5-HT 和 DA 途径的紊乱会导致核心饮食失调的病理生理学。该试点研究旨在确定最有效的剂量和副作用以及安全性/耐受性。如果这些目标得以实现，可能需要进行更大规模的双盲、安慰剂对照试验来证明主要和次要目标，并确定反应是否针对 AN 亚型。这项研究可能足以检测核心饮食失调症状的差异。 主要结果：首先，我们将力求证明喹硫平在减少耶鲁-布朗-康奈尔饮食失调量表（YBC-EDS）和饮食失调量表 2 的核心饮食失调症状方面优于安慰剂。 次要结果：我们将力求证明喹硫平在减少 DSM-IV AN（限制性或暴饮暴食）患者的焦虑 (STAI)、抑郁 (Hamilton DI)、强迫性 (YBOCS) 或体重增加 (BMI) 方面优于安慰剂。 - 饮食通便类型），持续 8 周。此外，我们将努力证明喹硫平在减少阳性和阴性症状量表（PANSS）上的阳性和阴性症状方面优于安慰剂。最后，我们将使用匹兹堡喹硫平药物管理评估和访谈来跟踪喹硫平的反应、过程和结果。