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: 7950944
• 负责人: WALTER KAYE
• 金额: $ 0.62万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950944
• 关键词: Adverse effects; Anorexia Nervosa; Anxiety; Binge Eating; Clinical Research; 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; Outcome; Pathway interactions; Patients; Pilot Projects; Placebos; Research; Research Personnel; Resources; Safety; Seroquel; Serotonin; Source; Symptoms; United States National Institutes of Health; Weight Gain; depression; double-blind placebo controlled trial; meetings; primary outcome; purge; quetiapine; response; secondary outcome

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 一些证据表明，5-HT和DA途径的干扰有助于核心进食障碍的病理生理学。这项初步研究旨在确定最有效的剂量和副作用特征以及安全性/耐受性。如果达到这些目标，可能需要进行更大规模的双盲、安慰剂对照试验，以证明主要和次要目标，并确定是否对AN亚型有特异性反应。这项研究可能有足够的把握度来检测核心进食障碍症状的差异。 主要结局：首先，我们将试图证明奎替卡松在减少耶鲁-布朗-康奈尔饮食失调量表（YBC-EDS）和饮食失调量表-2上的核心饮食失调症状方面优于安慰剂上级。 次要结局：我们将试图证明，当给药8周时，奎替鲁在减少DSM-IV AN患者（限制或暴饮暴食清除型）的焦虑（STAI）、抑郁（汉密尔顿DI）、强迫症（YBOCS）或体重增加（BMI）方面上级安慰剂。此外，我们将试图证明奎替鲁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上级。最后，我们将使用匹兹堡奎替尼药物管理评估和访谈来跟踪奎替尼的反应、过程和结果。