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Open Access Highly Accessed Study protocol

Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism

Anissa Mouti1*, Dinah Reddihough34, Catherine Marraffa4, Philip Hazell2, John Wray5, Katherine Lee34 and Michael Kohn1

Author Affiliations

1 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

2 Discipline of Psychiatry, Sydney Medical School, The University of Sydney, Hospital Rd, Concord West, 2138 Sydney, Australia

3 Department of Pediatrics, University of Melbourne, Flemington Road, 3052 Parkville, Australia

4 Murdoch Children’s Research Institute, Flemington Road, 3052 Parkville, Australia

5 State Child Development Centre, Rheola Street, 6872 West Perth, Australia

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Trials 2014, 15:230  doi:10.1186/1745-6215-15-230

Published: 16 June 2014

Abstract

Background

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.

Discussion

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.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12608000173392; registered on 9 April, 2008.

Keywords:
Autism Spectrum Disorder (ASD); Autism; Serotonin Reuptake Inhibitors (SSRIs); Fluoxetine; Repetitive and Restricted Behaviors; Randomized Controlled Trial (RCT); Drug Therapy; Children; Adolescents; Safety and Efficacy