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首页> 外文期刊>Journal of Eating Disorders >Understanding the neural mechanisms of lisdexamfetamine dimesylate (LDX) pharmacotherapy in Binge Eating Disorder (BED): a study protocol
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Understanding the neural mechanisms of lisdexamfetamine dimesylate (LDX) pharmacotherapy in Binge Eating Disorder (BED): a study protocol

机译：了解林司哌胺二甲磺酸盐（LDX）药物治疗的神经机制（床）：研究方案

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The efficacy and safety of Lisdexamfetamine dimesylate (LDX) in the treatment of moderate to severe binge eating disorder (BED) has been demonstrated in multiple randomised clinical trials. Despite this, little is known about how LDX acts to improve binge eating symptoms. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that LDX will act by normalising connectivity within neural circuits responsible for reward and impulse control, and that this normalisation will correlate with reduced binge eating episodes. This is an open-label Phase 4 clinical trial of LDX in adults with moderate to severe BED. Enrolment will include 40 adults with moderate to severe BED aged 18-40?years and Body Mass Index (BMI) of 20-45?kg/m2, and 22 healthy controls matched for age, gender and BMI. Clinical interview and validated scales are used to confirm diagnosis and screen for exclusion criteria, which include comorbid anorexia nervosa or bulimia nervosa, use of psychostimulants within the past 6?months, and current use of antipsychotics or noradrenaline reuptake inhibitors. Baseline assessments include clinical symptoms, multimodal neuroimaging, cognitive assessment of reward sensitivity and behavioural inhibition, and an (optional) genetic sample. A subset of these assessments are repeated after eight weeks of treatment with LDX titrated to either 50 or 70?mg. The primary outcome measures are resting-state intrinsic connectivity and the number of binge eating episodes. Analyses will be applied to resting-state fMRI data to characterise pharmacological effects across the functional connectome, and assess correlations with symptom measure changes. Comparison of neural measures between controls and those with BED post-treatment will also be performed to determine whether LDX normalises brain function. First enrolment was in May 2018, and is ongoing. This study is the first comprehensive investigation of the neurobiological changes that occur with LDX treatment in adults with moderate to severe BED. ACTRN12618000623291, Australian and New Zealand Clinical Trials Registry URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374913&isReview=true. Date of Registration: 20 April 2018.
机译：在多种随机临床试验中，已经证明了锂磷脂二甲胺二甲磺酸二甲酯（LDX）治疗中度至重度狂犬病疾病（床）的疗效和安全性。尽管如此，对于LDX如何改善狂暴吃症状而言，甚至所知。本研究旨在全面了解LDX改善床症状的神经机制。我们假设LDX将通过对负责奖励和脉冲控制负责的神经电路内的连通性进行标准，并且这种归一化将与减少的狂犬病剧集相关。这是一个开放标签阶段4临床试验的LDX在成人中，中度至严重床。入学将包括40名成人，中度至18-40岁的严重床，年龄和体重指数（BMI）为20-45岁，22例健康对照，符合年龄，性别和BMI。临床面试和验证的尺度用于确认排除标准的诊断和屏幕，包括可厌氧神经组织或贪食疗法，在过去的6个月内使用精神疗法，以及目前使用抗精神病药或去甲肾上腺素再摄取抑制剂。基线评估包括临床症状，多峰神经影像，奖励敏感性和行为抑制的认知评估，以及（可选）遗传样品。在用LDX滴定到50或70μg的LDX治疗后，将这些评估的子集重复。主要结果措施是休息状态的内在连通性和狂暴剧集的数量。分析将应用于休息状态的FMRI数据，以表征功能性连接的药理效应，并评估与症状测量变化的相关性。还将进行对照和床后治疗之间的神经措施的比较，以确定LDX是否正常脑功能。第一次注册是2018年5月，正在进行。本研究是第一次全面调查患有中度至重度床的成人的LDX治疗发生的神经生物学变化。 ACTRN12618000623291，澳大利亚和新西兰临床试验注册表网址：https://www.anzctr.org.au/trier/registration/trialreview.aspx?id=374913&isreview=true。注册日期：2018年4月20日。

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