Journal of autism and developmental disorders · 2020
The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Herscu Paul, Handen Benjamin L, Arnold L Eugene, Snape Michael F, Bregman Joel D, Ginsberg Lawrence, Hendren Robert, Kolevzon Alexander, Melmed Raun, Mintz Mark, Minshew Nancy, Sikich Linmarie, Attalla Ashraf, King Brian, Owley Thomas, Childress Ann, Chugani Harry, Frazier Jean, Cartwright Charles, Murphy Tanya, Autism Speaks Autism Clinical Trials Network
Аннотация
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.