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Gepubliceerd in: Journal of Autism and Developmental Disorders 9/2020

02-07-2019 | Original Paper

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

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

Gepubliceerd in: Journal of Autism and Developmental Disorders | Uitgave 9/2020

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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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Metagegevens
Titel
The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder
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
Publicatiedatum
02-07-2019
Uitgeverij
Springer US
Gepubliceerd in
Journal of Autism and Developmental Disorders / Uitgave 9/2020
Print ISSN: 0162-3257
Elektronisch ISSN: 1573-3432
DOI
https://doi.org/10.1007/s10803-019-04120-y