Therapeutic Placebos as Complementary Therapy in ADHD

治疗性安慰剂作为多动症的补充疗法

• 批准号: 6585631
• 负责人: ADRIAN D SANDLER
• 金额: $ 16.28万
• 依托单位: MH MISSION HOSPITAL, LLLP
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2005-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585631
• 关键词: anxiety; attention deficit disorder; behavioral /social science research tag; central nervous system stimulants; child behavior disorders; child mental disorders; clinical research; comorbidity; conduct disorder; depression; dosage; drug screening /evaluation; human subject; human therapy evaluation; interview; mental disorder chemotherapy; middle childhood (6-11); mood disorders; parents; patient oriented research; pharmacokinetics; placebos; psychopharmacology; teacher

DESCRIPTION (provided by applicant): This study will focus on an innovative complementary use of placebo. The purpose is to determine if pairing a placebo with stimulant medication produces a conditioned placebo response that allows children with ADHD to be maintained on a lower dose of stimulant medication. Conditioned placebo treatment would potentially enhance clinical care of children with ADHD by decreasing side effects. A sample of 80 children with ADHD will be recruited to participate in a three-phase study: (1) an initial double-blind dose finding phase to identify each child's optimal stimulant dose (2) a dose reduction phase to compare subjects randomly assigned to either conditioned placebo dose reduction (100 percent of dose PLUS placebo -> 50 percent of dose PLUS placebo) or dose reduction only condition (100 percent of dose -> 50 percent of dose), and (3) a treatment maintenance phase to examine the duration of conditioned placebo effects among positive responders. Treatment response will be measured by parent and teacher rating scales, objective measures of attention, and side effects. The conditioned placebo procedure to be examined involves daily pairing of the full stimulant dose with a visually distinctive placebo pill for 1 month followed by stimulant dose reduction with continuation of the placebo. This method carries the potential for eliciting a conditioned response as has been done in other medical treatment contexts that have demonstrated significant conditioned placebo responses (e.g. placebo treatment of pain). A visually distinctive placebo pill (color, size, and indicia distinct from the stimulant pill) will be used as previous research has shown that the visual characteristics of a placebo can enhance its positive effects. In a pilot study of placebo treatment in children with ADHD (n = 26) we found that approximately 40% of a sample of children with ADHD could be maintained on 50% of their typical dose of stimulant medication when dose reduction was accomplished using the conditioned placebo procedure. Specific aims of the proposed study are: (1) to determine the efficacy, side effects and acceptability of conditioned placebo treatment, (2) to examine specific treatment effects and persistence of effects over time, and (3) to identify predictors of conditioned placebo response.

描述(由申请人提供)：这项研究将集中在安慰剂的创新补充使用上。目的是确定将安慰剂与兴奋剂药物配对是否会产生条件性安慰剂反应，使ADHD儿童能够继续服用较低剂量的兴奋剂药物。有条件的安慰剂治疗可能会通过减少副作用来加强ADHD儿童的临床护理。80名ADHD儿童样本将被招募参加一项分三个阶段的研究：(1)初始双盲剂量寻找阶段，以确定每个儿童的最佳兴奋剂剂量；(2)剂量减少阶段，以比较随机分配到条件安慰剂剂量减少(100%剂量加安慰剂；50%剂量加安慰剂)或仅剂量减少条件(剂量100%加安慰剂50%)的受试者，以及(3)治疗维持阶段，以检查阳性反应者条件安慰剂效应的持续时间。治疗反应将通过家长和教师评级量表、注意力的客观衡量标准和副作用来衡量。接受检查的有条件的安慰剂程序包括每天将全部兴奋剂剂量与视觉上独特的安慰剂药片配对1个月，然后在继续服用安慰剂的情况下减少兴奋剂剂量。这种方法具有引发条件性反应的潜力，就像在其他已经显示出显著的条件性安慰剂反应的医疗环境中所做的那样(例如，疼痛的安慰剂治疗)。一种视觉上独特的安慰剂药丸(颜色、大小和标记与兴奋剂药丸不同)将被使用，因为先前的研究表明，安慰剂的视觉特征可以增强其积极效果。在一项针对ADHD儿童的安慰剂治疗的初步研究中(n=26)，我们发现，当使用条件安慰剂程序完成剂量减少时，ADHD儿童样本中约40%的ADHD儿童可以在50%的典型刺激性药物剂量下维持下去。这项研究的具体目的是：(1)确定条件性安慰剂治疗的有效性、副作用和可接受性，(2)检查特定的治疗效果和随着时间的推移效果的持久性，(3)确定条件性安慰剂反应的预测因素。