Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Jun 16:15:230.
doi: 10.1186/1745-6215-15-230.

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

Anissa Mouti  1 , Dinah Reddihough, Catherine Marraffa, Philip Hazell, John Wray, Katherine Lee, Michael Kohn
Affiliations
Randomized Controlled Trial

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

Anissa Mouti et al. Trials. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
FAB consort flow diagram.
See this image and copyright information in PMC

References

    1. Williams K, Macdermott S, Ridley G, Glasson EJ, Wray JA. The Prevalence of Autism in Australia. Can it be established from existing data? J Paediatr Child Health. 2008;44(9):504–510. doi: 10.1111/j.1440-1754.2008.01331.x. - DOI - PubMed
    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth. Arlington, VA: American Psychiatric Publishing; 2013.
    1. Soorya L, Kiarashi J, Hollander E. Psychopharmacologic interventions for repetitive behaviors in autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008;17:753–771. doi: 10.1016/j.chc.2008.06.003. - DOI - PubMed
    1. Williams K, Brignell A, Randall M, Silove N, Hazell P. Selective serotonin reuptake inhibitors (SSRIs) for autism spectrum disorders (ASD) Cochrane Database Syst Rev. 2013;8:CD004677. - PMC - PubMed
    1. Billstedt E, Gillberg IC, Gillberg C. Autism after adolescence: population-based 13- to 22-year follow-up study of 120 individuals with autism diagnosed in childhood. J Autism Dev Disord. 2005;35:351–360. doi: 10.1007/s10803-005-3302-5. - DOI - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources