Mouti Anissa, Reddihough Dinah, Marraffa Catherine, Hazell Philip, Wray John, Lee Katherine, Kohn Michael
Centre for Research into Adolescent's Health (CRASH), Sydney Children's Hospital Network, Westmead Sydney Medical School, The University of Sydney, Hawkesbury Road, 2145 Sydney, Australia.
Trials. 2014 Jun 16;15:230. doi: 10.1186/1745-6215-15-230.
Serotonin reuptake inhibitors (SSRIs) are commonly prescribed off-label for children with autism. To date, clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice. The aim of the Fluoxetine for Autistic Behaviors (FAB) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo, for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder (ASD). The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored.
METHODS/DESIGN: The FAB study is a multicenter, double-blinded, randomized controlled trial, funded by the Australian Government's National Health and Medical Research Council (NHMRC) grant. Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD. Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period. Medication will be titrated over the first four weeks. Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale (CGI). The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders (CYBOCS-PDD), administered at baseline and 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), the Spence Children's Anxiety Scale Parent Report (SCAS-P), and the Repetitive Behaviors Scale (RBS-R), measured at baseline and 16 weeks. Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab. Continuous outcomes, including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression. Binary outcomes will be compared using unadjusted logistic regression.
The FAB study is a large clinical trial to specifically investigate the efficacy of low dose fluoxetine for restricted, repetitive, and stereotyped behaviors in ASD. The outcomes of this study will contribute to evidence-based interventions used in clinical practice to assist children with ASD.
Australian and New Zealand Clinical Trials Registry ACTRN12608000173392; registered on 9 April, 2008.
5-羟色胺再摄取抑制剂（SSRIs）常用于自闭症儿童的非适应症用药。迄今为止，针对自闭症患者使用SSRIs的临床试验因样本量小和结果不确定而受到限制。SSRIs调节自闭症行为的疗效和安全性尚未得到充分研究，无法为当前临床实践提供支持证据。自闭症行为氟西汀（FAB）研究的目的是确定低剂量氟西汀与安慰剂相比，在降低自闭症谱系障碍（ASD）儿童和青少年重复刻板行为的频率和严重程度方面的疗效和安全性。还将探讨氟西汀治疗效果与5-羟色胺转运体基因型之间的关系。
方法/设计：FAB研究是一项多中心、双盲、随机对照试验，由澳大利亚政府国家卫生与医学研究委员会（NHMRC）资助。参与者年龄在7.5至17岁之间，确诊为ASD。符合条件的参与者将被随机分为安慰剂组或氟西汀组，为期16周。药物将在头四周内滴定。每两周使用临床总体印象量表（CGI）监测对药物的反应。主要结局指标是用于广泛性发育障碍的儿童耶鲁-布朗强迫症量表修订版（CYBOCS-PDD），在基线和16周时进行测量。次要结局指标包括异常行为量表（ABC）、斯彭斯儿童焦虑量表家长报告版（SCAS-P）和重复行为量表（RBS-R），在基线和16周时进行测量。将邀请参与者使用颊拭子进行SLC6A4等位基因变异的基因检测。使用未调整的线性回归比较活性组和安慰剂组之间的连续结局，包括主要结局。使用未调整的逻辑回归比较二元结局。
FAB研究是一项大型临床试验，专门研究低剂量氟西汀对ASD中受限、重复和刻板行为的疗效。本研究的结果将有助于临床实践中基于证据的干预措施，以帮助ASD儿童。
澳大利亚和新西兰临床试验注册中心ACTRN12608000173392；于2008年4月9日注册。
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