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）：本研究将侧重于安慰剂的创新互补使用。目的是确定将安慰剂与兴奋剂配对是否会产生条件的安慰剂反应，使患有多动症的儿童可以保持在较低剂量的刺激性药物上。条件安慰剂治疗将通过降低副作用来增强多动症儿童的临床护理。将招募80名ADHD儿童的样本参加三阶段研究：（1）初始双盲剂量查找阶段，以确定每个孩子的最佳刺激剂量（2）降低剂量的阶段，以随机分配给受试者，比较有条件的安慰剂剂量减少的受试者（仅剂量和剂量的dose plus dose plus dose plus dose plus -depbo）的100％ - > 50％的dose plus -plus -depbo -> 50％ - > 50％ - > 50％的剂量 - > 50％>> 50％>> 50％的剂量 - > 50％>剂量）和（3）一个治疗维持阶段，以检查阳性响应者中条件安慰剂效应的持续时间。 治疗反应将通过父母和教师评分量表，客观的注意力和副作用来衡量。要检查的条件安慰剂程序涉及每天将全部刺激剂量与视觉上独特的安慰剂药物配对1个月，然后降低刺激性剂量，并继续安慰剂。这种方法具有引起条件反应的潜力，就像在其他医疗治疗环境中所做的那样，这些治疗环境表现出明显的安慰剂反应（例如安慰剂治疗疼痛）。由于先前的研究表明，安慰剂的视觉特征可以增强其积极作用，因此将使用视觉上独特的安慰剂药（颜色，大小和与刺激性药丸不同）。在一项针对ADHD儿童的安慰剂治疗的试点研究（n = 26），我们发现，使用条件安慰剂手术减少剂量时，可以将约40％的ADHD儿童样本维持在其典型剂量的刺激药物中的50％。拟议研究的具体目的是：（1）确定条件安慰剂治疗的疗效，副作用和可接受性，（2）检查特定的治疗效果和效果的持续性，以及（3）识别条件安慰剂反应的预测因子。