학술논문
The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder.
Document Type
Article
Author
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
Source
Subject
*ANALYSIS of covariance
*AUTISM
*CHILD behavior
*DIARRHEA
*DRUG side effects
*FLUOXETINE
*INSOMNIA
*STATISTICAL sampling
*SEROTONIN uptake inhibitors
*TEENAGERS' conduct of life
*VOMITING
*RANDOMIZED controlled trials
*BLIND experiment
*DATA analysis software
*DESCRIPTIVE statistics
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Language
ISSN
0162-3257
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. [ABSTRACT FROM AUTHOR]