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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Anissa Mouti, Dinah Reddihough, Catherine Marraffa, Philip Hazell, John Wray, Katherine Lee, Michael Kohn

Published in: Trials | Issue 1/2014

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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 ACTRN12608000173​392; registered on 9 April, 2008.
Appendix
Available only for authorised users
Literature
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. 10.1111/j.1440-1754.2008.01331.x.CrossRefPubMed
2.
American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 2013, Arlington, VA: American Psychiatric Publishing, Fifth
3.
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. 10.1016/j.chc.2008.06.003.CrossRefPubMed
4.
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-PubMed
5.
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. 10.1007/s10803-005-3302-5.CrossRefPubMed
6.
Howlin P, Goode S, Hutton J, Rutter M: Adult outcome for children with autism. J Child Psychol Psychiatry. 2004, 45: 212-229. 10.1111/j.1469-7610.2004.00215.x.CrossRefPubMed
7.
Oswald D, Sonenklar N: Medication use among children with autism spectrum disorder. J Child Adolesc Psychopharmacol. 2007, 17: 348-355. 10.1089/cap.2006.17303.CrossRefPubMed
8.
Aman MG, Lam KSL, Collier- Crespin A: Prevalence and patterns of use of psychoactive medicines among individuals with autism in the Autism Society of Ohio. J Autism Developmental Disorders. 2003, 33: 527-534. 10.1023/A:1025883612879.CrossRef
9.
Langworthy-Lam KS, Aman MG, Van Bourgondien ME: Prevalence and patterns of use of psychoactive medicines in individuals with autism in the Autism Society of North Carolina. J Child Adolesc Psychopharmacol. 2002, 12: 311-321. 10.1089/104454602762599853.CrossRefPubMed
10.
Cook EH, Rowlett R, Jaselskis C, Leventhal BL: Fluoxetine treatment of children and adults with autistic disorder and mental retardation. J Am Acad Child Adolesc Psychiatry. 1992, 31: 739-745. 10.1097/00004583-199207000-00024.CrossRefPubMed
11.
McDougle CJ, Naylor ST, Cohen DJ, Aghajanian GK, Heninger GR, Price LH: Effects of tryptophan depletion in drug-free adults with autistic disorder. Arch Gen Psychiatry. 1996, 53: 993-1000. 10.1001/archpsyc.1996.01830110029004.CrossRefPubMed
12.
Sugie Y, Sugie H, Fukuda T, Ito M, Sasada Y, Nakabayashi M, Fukashiro K, Ohzeki T: Clinical efficacy of fluvoxamine and functional polymorphism in a serotonin transporter gene on childhood autism. J Autism Dev Disord. 2005, 35: 377-385. 10.1007/s10803-005-3305-2.CrossRefPubMed
13.
Hollander E, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, Iyengar R: A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology. 2005, 30: 582-589. 10.1038/sj.npp.1300627.CrossRefPubMed
14.
American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 2000, Washington DC: American Psychiatric Association, Text Revision- fourth
15.
McDougle CJ, Naylor ST, Cohen DJ, Volkmar FR, Heninger GR, Price LH: A double-blind, placebo-controlled study of fluvoxamine in adults with autistic disorder. Arch Gen Psychiatry. 1996, 53: 1001-1008. 10.1001/archpsyc.1996.01830110037005.CrossRefPubMed
16.
Rutter M, Le Couteur A, Lord C: ADI-R: Autism diagnostic interview revised. WPS edition manual. 2003, Los Angeles, CA: Western Psychological Services
17.
Wechsler D: Wechsler Intelligence Scale for Children- Fourth Edition. Australian Administration and Scoring Manual. 2003, Marrickville Sydney: Hardcourt Assessment
18.
Wechsler D: Wechsler Adult Intelligence Scale – Fourth Edition. Australian Administration and Scoring Manual. 2008, Marrickville Sydney: Hardcourt Asssessment
19.
Wechsler D, Naglieri JA: Wechsler Nonverbal Scale of Ability. Administration and Scoring Manual. 2006, San Antonio TX: Harcourt Assessment
20.
Scahill L, Riddle MA, McSwiggin-Hardin M, Ort S, King R, Goodman W, Cicchetti D, Leckman J: Am Acad Child Adolesc Psychiatry. 1997, 36: 844-852. 10.1097/00004583-199706000-00023.CrossRef
21.
Guy W: ECDEU assessment manual for psychopharmacology. 1976, Maryland Washington DC: US Department of Health, Education and Welfare
22.
Lam KSL, Aman MG: The Repetitive Behavior Scale-Revised: independent validation in individuals with autism spectrum disorders. J Autism Dev Disord. 2007, 37: 855-866. 10.1007/s10803-006-0213-z.CrossRefPubMed
23.
Spence SH: A measure of anxiety symptoms among children. Behav Res Ther. 1998, 36: 545-566. 10.1016/S0005-7967(98)00034-5.CrossRefPubMed
24.
Nauta MH, Scholing A, Rapee RM, Abbott M, Spence SH, Waters A: A parent-report measure of children’s anxiety: psychometric properties and comparison with child-report in a clinic and normal sample. Behav Res Ther. 2004, 42: 813-839. 10.1016/S0005-7967(03)00200-6.CrossRefPubMed
25.
Spence SH, Barrett PM, Turner CM: Psychometric properties of the Spence Children’s Anxiety Scale with young adolescents. J Anxiety Disord. 2003, 17: 605-625. 10.1016/S0887-6185(02)00236-0.CrossRefPubMed
26.
Brinkley J, Nations L, Abramson RK, Hall A, Wright H, Gabriels R, Gilbert J, Pericak- Vance , Cuccaro J: Factor analysis of the aberrant behavior checklist in individuals with autism spectrum disorders. J Autism Dev Disord. 2007, 37: 1949-1959. 10.1007/s10803-006-0327-3.CrossRefPubMed
27.
Scahill L, McDougle C, Williams S, Dimitropoulos A, Aman M, McCracken J, Tierney E, Arnold L, Cronin P, Grados M, Ghuman J, Koenig K, Lam K, McGough J, Posey D, Ritz L, Swiezy N, Vitiello B: Children’s Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders. J Am Acad Child Adolesc Psychiatry. 2006, 45: 1114-1123. 10.1097/01.chi.0000220854.79144.e7.CrossRefPubMed
28.
Cook EH, Leventhal BL: The serotonin system in autism. Curr Opin Pediatr. 1996, 8: 348-354. 10.1097/00008480-199608000-00008.CrossRefPubMed
29.
McDougle C, Kresch L, Posey D: Repetitive thoughts and behaviour in pervasive developmental disorders: Treatment with serotonin reuptake inhibitors. J Autism Dev Disord. 2000, 30: 427-435. 10.1023/A:1005551523657.CrossRefPubMed
Metadata
Title
Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism
Authors
Anissa Mouti
Dinah Reddihough
Catherine Marraffa
Philip Hazell
John Wray
Katherine Lee
Michael Kohn
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-230

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