The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder
Department of Psychiatry; Eunice Kennedy Shriver Center
Health Services Administration | Health Services Research | Mental and Social Health | Pediatrics | Psychiatry | Psychiatry and Psychology
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.
Autism spectrum disorder, Repetitive behavior, Selective seretonin reuptake inhibitor
DOI of Published Version
J Autism Dev Disord. 2019 Jul 2. doi: 10.1007/s10803-019-04120-y. [Epub ahead of print] Link to article on publisher's site
Journal of autism and developmental disorders
Herscu P, Handen BL, Frazier JA. (2019). The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. Psychiatry Publications. https://doi.org/10.1007/s10803-019-04120-y. Retrieved from https://escholarship.umassmed.edu/psych_pp/866