Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder

暴食症的认知行为和药物治疗

• 批准号: 10188514
• 负责人: CARLOS M GRILO
• 金额: $ 69.58万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10188514
• 关键词: Acute; Address; Binge Eating; Binge eating disorder; Body Weight decreased; Bupropion; Clinical; Clinical Treatment; Cognitive Therapy; Comparative Effectiveness Research; Data; Double-Blind Method; Eating Disorders; Effectiveness; FDA approved; Fluoxetine; Generations; Impairment; Intervention; Maintenance; Mediator of activation protein; Methods; Minority; Morbidity - disease rate; Naltrexone; Obesity; Outcome; Outcome Assessment; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Placebos; Prevalence; Public Health; Randomized; Randomized Controlled Trials; Relapse; Reporting; Research; Specificity; Testing; Treatment Effectiveness; Treatment outcome; Vyvanse; Work; active method; biopsychosocial; comparative effectiveness; compare effectiveness; cost effectiveness; cost estimate; effectiveness evaluation; effectiveness testing; follow-up; improved; novel; obese patients; outcome prediction; psychologic; relative effectiveness; response; treatment effect

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED and obesity are needed that can produce sustained clinical outcomes. This study aims to perform a two-stage randomized controlled trial (RCT) to compare the effectiveness of two leading but distinct treatments — lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) — alone and in combination, for BED. LDX is the only FDA-approved medication for BED, has demonstrated short-term effectiveness relative to placebo, but comparative effectiveness to other active treatments and longer-term outcomes are unknown. The first stage RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for obese patients with BED. The second stage RCT will provide novel findings from a controlled test, whether amongst Stage 1 patients who received acute pharmacotherapy with LDX (i.e., LDX or CBT+LDX) and showed a positive clinical response, continued LDX medication results in superior maintenance and longer-term outcomes than placebo. The second Stage RCT will also provide novel findings regarding whether amongst non-responders to Stage 1 pharmacotherapy, switching to an alternative medication (Naltrexone-Bupropion; FDA-approved for obesity) results in clinical improvements. This study addresses the dearth of research on longer-term outcomes of pharmacotherapy for BED, which is strikingly at odds with the public health significance of BED, including documented prevalence, strong association with obesity, and heightened bio-psychosocial morbidity. In Stage 1 RCT, N=180 obese patients with BED will be randomly assigned to one of three 12-week interventions: CBT, LDX, or CBT+LDX. In Stage 2, patients who received acute pharmacotherapy (LDX or CBT+LDX) and were “responders” (65% or greater reduction in binge eating) will be randomized in equal proportions (stratified blocked randomization with first treatment as stratifying variable) to LDX or placebo (double-blind) for 12 weeks. “Non-responders” to acute pharmacotherapy will be randomized to a second medication (Naltrexone-Bupropion or placebo; double-blind) for 12 weeks. Stage 1 patients receiving CBT will be followed without further intervening treatment. Independent outcome assessments will determine relative acute effectiveness, medication maintenance effectiveness, and longer-term maintenance through 18 months. Secondary aims are to contribute important new data regarding predictors of outcomes and moderators of treatment effects to inform prescription (i.e., for whom the LDX and CBT work best), exploration of mediators through which these two distinct methods work, exploration of alternmative pharmacotherapy for initial non- responders, and generation of cost-effectiveness estimates. This study will produce novel findings regarding “adaptive” SMART treatment methods for BED and obesity.

暴饮暴食障碍（BED）是最普遍的形式饮食失调，与肥胖和 生物心理社会障碍。需要改善床和肥胖症患者的治疗方法 产生了持续的临床结果。 这项研究旨在进行两阶段的随机对照试验（RCT），以比较 两种领先但独特的治疗方法 - 单独 并结合床。 LDX是唯一的床FDA批准药物，已证明短期 相对于安慰剂的有效性，但对其他主动治疗和长期的比较有效性 结果未知。第一阶段RCT将提供有关相对有效性的新发现 肥胖患者的LDX，CBT和CBT+LDX组合。第二阶段的RCT将提供新颖 来自受控测试的发现，是否在接受急性药物治疗的1阶段患者中 LDX（即LDX或CBT+LDX），显示出阳性的临床反应，持续的LDX药物导致 优越的维护和长期结局比安慰剂。第二阶段的RCT也将提供新颖 关于在非应答者到第1期药物疗法中是否转向替代方案中的发现 药物（Naltrexone-Bupropion; FDA批准用于肥胖）会导致临床改善。这项研究 解决了有关卧床药物长期结局的研究死亡，这令人惊讶 与床的公共卫生意义相关，包括有记录的患病率，与 肥胖和生物心理社会发病率提高。 在第1阶段RCT中，n = 180个肥胖患者将随机分配给三个12周的三个 干预措施：CBT，LDX或CBT+LDX。在第2阶段，接受急性药物治疗的患者（LDX或 CBT+LDX）和“响应者”（暴饮暴食减少65％或更高）将被随机分配 比例（以第一次处理为分层变量的分层封闭的随机化）或安慰剂 （双盲）持续12周。急性药物治疗的“非反应器”将随机分为第二秒 药物（Naltrexone-Bupopion或安慰剂；双盲）12周。 1阶段接受CBT的患者将 遵循无进一步的干预治疗。独立的结果评估将确定相对 急性有效性，维持效率和长期维护至18个月。 次要目的是为结果和主持人的预测指标提供重要的新数据 治疗效果以告知处方（即，对LDX和CBT效果最好），探索调解人 通过这两种不同的方法起作用，探索替代药物治疗的初始非 - 响应者和成本效益估计的产生。 这项研究将产生有关床和肥胖的“适应性”智能治疗方法的新发现。