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]