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）：本研究将重点关注安慰剂的创新补充使用。目的是确定安慰剂与兴奋剂药物配对是否会产生条件性安慰剂反应，使患有多动症的儿童能够维持较低剂量的兴奋剂药物。条件安慰剂治疗可能会通过减少副作用来加强对多动症儿童的临床护理。将招募 80 名 ADHD 儿童作为样本，参与一项三阶段研究：(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，比较随机分配的受试者条件性安慰剂剂量减少（剂量的 100% 加安慰剂 -> 剂量的 50% 加安慰剂）或仅剂量减少条件（剂量的 100% -> 剂量的 50%），以及(3) 治疗维持阶段，用于检查阳性反应者中条件安慰剂效应的持续时间。 治疗反应将通过家长和老师的评分量表、客观的注意力测量和副作用来衡量。要检查的条件安慰剂程序包括每天将完整的兴奋剂剂量与视觉上独特的安慰剂药丸配对，持续 1 个月，然后减少兴奋剂剂量并继续使用安慰剂。这种方法具有引发条件反应的潜力，就像在其他医疗环境中所做的那样，这些治疗环境已经证明了显着的条件安慰剂反应（例如疼痛的安慰剂治疗）。将使用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），因为先前的研究表明安慰剂的视觉特征可以增强其积极作用。在一项对 ADHD 儿童进行安慰剂治疗的初步研究中（n = 26），我们发现，当使用条件疗法完成剂量减少时，大约 40% 的 ADHD 儿童样本可以维持其典型剂量的 50% 的兴奋剂药物。安慰剂程序。拟议研究的具体目的是：（1）确定条件安慰剂治疗的功效、副作用和可接受性，（2）检查特定治疗效果和效果随时间的持续性，以及（3）确定条件安慰剂的预测因素回复。