Multi-Site Randomized Controlled Trial of Fluoxetine in Children and Adolescents with Autism (FAB)

Friday, May 12, 2017: 5:00 PM-6:30 PM
Golden Gate Ballroom (Marriott Marquis Hotel)
A. Mouti1, M. Kohn2, D. Reddihough3, C. Marraffa4, P. Hazell5, J. Wray6, K. Lee7, P. J. Santosh8, D. Dossetor9, N. Silove10, A. J. Whitehouse11, J. Granich12, M. O'Sullivan13, F. Orsini14 and P. Lockhart14, (1)Sydney Children's Hospital Network, Westmead/Sydney Medical School, The University of Sydney/Centre for Research into Adolescent's Health (CRASH), Westmead, Australia, (2)Sydney Children's Hospital Network, Westmead/Westmead Hospital/Centre for Research into Adolescent's Health (CRASH), Sydney, Australia, (3)Royal Children's Hospital, Parkville, AUSTRALIA, (4)Royal Children's Hospital Flemington Rd Parkville 3052 Victoria, Australia, Parkville, AUSTRALIA, (5)Sydney Medical School, The University of Sydney/ Centre for Research into Adolescent's Health (CRASH), Westmead, Australia, (6)Child Development Service, Child and Adolescent Health Service/University of Western Australia, WA, Perth, AUSTRALIA, (7)Murdoch Childrens Research Institute/Department of Paediatrics, University of Melbourne, Parkville, Australia, (8)Centre for Interventional Paediatric Psychopharmacology and Rare Diseases (CIPPRD), Child & Adolescent Mental Health, Institute of Psychiatry, Psychology & Neurosciences, King's College London; Maudsley Hospital, London, London, United Kingdom, (9)Department of Psychological Medicine, Sydney Children’s Hospital Network Westmead (NSW) /Sydney Medical School, The University of Sydney, Westmead, Australia, (10)Sydney Children’s Hospital Network Westmead (NSW)/Sydney Medical School, The University of Sydney, Sydney, AUSTRALIA, (11)Telethon Kids Institute, University of Western Australia, Perth, Australia, (12)Telethon Kids Institute, Telethon Kids Institute, Subiaco, Australia, (13)Developmental Disability & Rehabilitation Research, Murdoch Childrens Research Institute, Parkville, Australia, (14)Murdoch Childrens Research Institute, Parkville, Australia

Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed ‘off -label’ for children with Autism Spectrum Disorder (ASD) despite caution regarding their use. To date, clinical trials examining the use of SSRIs in ASD have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating repetitive stereotyped mannerisms in children with ASD is yet to be examined.


  1. To determine the efficacy of low- dose fluoxetine compared to placebo, for reducing the frequency and severity of restricted, repetitive and stereotypic behaviours in children and adolescents with an Autism Spectrum Disorder (ASD). 
  2. To assess the safety of using low- dose fluoxetine. 
  3. To explore the relationship between the effectiveness of low- dose fluoxetine and the serotonin transporter genotype.


The FAB study is a multi-site randomized controlled trial. As at October 2016, 142 participants aged between 7.5-17 years with a confirmed DSM-IV-TR diagnosis of ASD have been recruited and randomized over a 6 year period. Following pre- assessment, eligible participants are randomized to either placebo or active fluoxetine groups with medication being titrated upwards over a four-week period. Reponses to medication are monitored on a weekly/fortnightly basis 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) at 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), Spence Children’s Anxiety Scale Parent version (SCAS-P) and the Repetitive Behaviours Scale (RBS-R) also at 16 weeks. Participants were also invited to undergo genetic testing for SLC6A4 allele variants via a cheek swab. Outcome will be compared between the groups using linear (continuous outcomes) and logistic (binary outcomes).


Please note, at the time of this abstract submission results were not available but will be available during the conference time period in May 2017.



The FAB study is the first adequately powered randomized controlled trial to specifically investigate the efficacy and safety of low dose fluoxetine for restricted, repetitive and stereotyped behaviours in children with ASD.