EFFECT OF FLUOXETINE ORALLY DISSOLVING TABLET (ODT) ON REPETITIVE BEHAVIORS

氟西汀口腔溶解片 (ODT) 对重复行为的影响

• 批准号: 7718205
• 负责人: ALEXANDER KOLEVZON
• 金额: $ 0.06万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718205
• 关键词: Adolescent; Behavior; Caregivers; Child; Clinical; Computer Retrieval of Information on Scientific Projects Database; Daily; Disease; Dose; Double-Blind Method; Family; Feeling; Fluoxetine; Funding; Grant; Institution; Life; Measures; Multicenter Studies; Oral; Parents; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Randomized; Reporting; Research; Research Personnel; Resources; Source; Symptoms; Tablets; Therapeutic Effect; Time; United States National Institutes of Health; Week

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 11/27/2007 Hypothesis: This randomized, double-blind, placebo-controlled, parallel-group, 14-week multicenter study will investigate the effect of fluoxetine orally dissolving tablet (ODT) on the repetitive behaviors core domain in children and adolescents with autistic spectrum disorder (ASD). The study will also investigate the effect of fluoxetine ODT on the improvement of symptoms (measured principally through parent report to the evaluator and through evaluator observation) and the effects on daily living on the patient's family (burden, feelings and related items). The primary objective for the study is to evaluate the effects of titrated doses of once-daily oral fluoxetine ODT in a multicenter setting on the repetitive behavior domain in children and adolescent patients with ASD as measured by the mean percent change from baseline in the compulsion subscale of the CYBOCS-PDD compared to placebo at Week 14 or the last assessment. Secondary objectives for the study are to evaluate the time- and dose-related course of therapeutic effects, the inter-relationships between these effects in the context of global clinical changes, and the indirect effects on patient caregivers of titrated doses of once-daily oral fluoxetine ODT in children and adolescent patients with ASD compared to placebo during 14 weeks of drug treatment in a multicenter setting.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 11/27/2007 假设： 本研究采用随机、双盲、安慰剂对照、平行分组、多中心、为期14周的研究方法，探讨氟西汀口服溶片（ODT）对自闭症谱系障碍（ASD）儿童青少年重复行为核心域的影响。 本研究还将研究氟西汀ODT对症状改善的影响（主要通过父母向评价者报告和通过评价者观察进行测量）以及对患者家庭日常生活的影响（负担、感觉和相关项目）。 本研究的主要目的是在多中心环境中评价滴定剂量每日一次口服氟西汀ODT对ASD儿童和青少年患者重复行为领域的影响，通过第14周或末次评估时与安慰剂相比CYBOCS-PDD强迫子量表较基线的平均百分比变化进行测量。 本研究的次要目的是在一项多中心研究中，评价在ASD儿童和青少年患者中，与安慰剂相比，在14周的药物治疗期间，每日一次口服氟西汀ODT滴定剂量对患者护理人员的间接影响，以及与时间和剂量相关的治疗效应过程、这些效应在全球临床变化背景下的相互关系。