The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder

J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.

Abstract

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD.Trial Registration: clinicaltrials.gov Identifier: NCT00515320.

Keywords: Autism spectrum disorder; Repetitive behavior; Selective seretonin reuptake inhibitor.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Autistic Disorder / diagnosis*
  • Autistic Disorder / drug therapy*
  • Autistic Disorder / psychology
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Fluoxetine / administration & dosage*
  • Humans
  • Male
  • Selective Serotonin Reuptake Inhibitors / administration & dosage*
  • Stereotypic Movement Disorder / diagnosis*
  • Stereotypic Movement Disorder / drug therapy*
  • Stereotypic Movement Disorder / psychology
  • Treatment Outcome

Substances

  • Serotonin Uptake Inhibitors
  • Fluoxetine

Associated data

  • ClinicalTrials.gov/NCT00515320