Title

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

UMMS Affiliation

Department of Psychiatry; Eunice Kennedy Shriver Center

Publication Date

2019-07-02

Document Type

Article

Disciplines

Health Services Administration | Health Services Research | Mental and Social Health | Pediatrics | Psychiatry | Psychiatry and Psychology

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.

Keywords

Autism spectrum disorder, Repetitive behavior, Selective seretonin reuptake inhibitor

DOI of Published Version

10.1007/s10803-019-04120-y

Source

J Autism Dev Disord. 2019 Jul 2. doi: 10.1007/s10803-019-04120-y. [Epub ahead of print] Link to article on publisher's site

Journal/Book/Conference Title

Journal of autism and developmental disorders

Comments

Full author list omitted for brevity. For the full list of authors, see article.

Related Resources

Link to Article in PubMed

PubMed ID

31267292

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