FLUOXETINE vs. PLACEBO IN CHILD/ADOLESCENT AUTISTIC DISORDER

虽然在临床实践中，氟西汀经常被开给自闭症患者，但其疗效、副作用、维持和停药效应尚未确定。疗效的结果参差不齐，特别是青春期前和青春期后的患者之间，加上缺乏良好对照的试验，使得我们对SSRI的了解存在许多空白，例如氟西汀治疗自闭症。此外，重要的是要确定特定亚型的个体(那些重复行为增加的个体)或那些具有特定遗传变异或5-羟色胺系统多态的个体是否对氟西汀有不同的反应。针对自闭症重复行为领域的药物几乎没有受控数据，这有助于 严重的功能障碍。这项研究将比较液体氟西汀和安慰剂在治疗中的作用。 儿童/青少年自闭症患者，评估剂量、血液水平和治疗反应之间的关系。我们将研究5-羟色胺系统的候选基因、症状改善和副作用之间的关系。这项研究将包括三个治疗阶段：第一阶段--为期12周的双盲安慰剂控制的平行急性治疗阶段，第二阶段--为期12周的治疗延长阶段，以及第三阶段--为期12周的双盲安慰剂控制的停止阶段。我们的目标是评估对具有重复行为的自闭症儿童分层样本的核心症状领域的有针对性的治疗，以及 探讨5-羟色胺系统基因变异与氟西汀治疗反应及副作用的关系。

While fluoxetine is frequently prescribed to autistic patients in clinical practice, its efficacy, side effects, maintenance and discontinuation effects have not been definitively established. Mixed results of efficacy, particularly between pre- and post-pubertal patients, and a lack of well-controlled trials leave many gaps in our knowledge about SSRIs, such as fluoxetine, in autism. Furthermore, it is important to determine whether specific subtypes of individuals (those with increased repetitive behaviors), or those with specific genetic variants or polymorphisms of the serotonin system respond differentially to fluoxetine. Little controlled data is available with medications that target the repetitive behavior domain of autism, which contributes to substantial functional impairment. This study will compare liquid fluoxetine vs. placebo in treating child/adolescent autistic patients and assess the relationship between dose, blood levels and response to treatment. The relationship between candidate genes of the serotonin system, symptom improvement, and side effects will be examined. The study will consist of three treatment phases: Phase 1 - a 12-week doubleblind placebo-controlled parallel acute treatment phase, Phase 2 - a 12-week treatment extension phase, and Phase 3 - a 12-week double-blind placebo-controlled discontinuation phase. We aim to evaluate a targeted treatment of a core symptom domain in a stratified sample of autistic children with repetitive behavior, and explore the relationship between genetic variation of the 5-HT system and fluoxetine treatment response and side effects.