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02-07-2019 | Original Paper | Uitgave 9/2020

Journal of Autism and Developmental Disorders 9/2020

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

Tijdschrift:
Journal of Autism and Developmental Disorders > Uitgave 9/2020
Auteurs:
Paul Herscu, Benjamin L. Handen, L. Eugene Arnold, Michael F. Snape, Joel D. Bregman, Lawrence Ginsberg, Robert Hendren, Alexander Kolevzon, Raun Melmed, Mark Mintz, Nancy Minshew, Linmarie Sikich, Ashraf Attalla, Brian King, Thomas Owley, Ann Childress, Harry Chugani, Jean Frazier, Charles Cartwright, Tanya Murphy, the Autism Speaks Autism Clinical Trials Network
Belangrijke opmerkingen
Deceased—Thomas Owley.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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.

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