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

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Title: The SOFIA Study: Negative Multi-Center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder
Language: English
Authors: 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: Journal of Autism and Developmental Disorders. Sep 2020 50(9):3233-3244.
Availability: Springer. Available from: Springer Nature. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: customerservice@springernature.com; Web site: https://link.springer.com/
Peer Reviewed: Y
Page Count: 12
Publication Date: 2020
Document Type: Journal Articles
Reports - Research
Descriptors: Autism, Pervasive Developmental Disorders, Drug Therapy, Symptoms (Individual Disorders), Anxiety Disorders, Comparative Analysis, Children, Adolescents, Outcomes of Treatment
DOI: 10.1007/s10803-019-04120-y
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 [adverse events] (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. [The Autism Speaks Autism Clinical Trials Network contributed to the writing of this article.]
Abstractor: As Provided
Entry Date: 2020
Accession Number: EJ1264163
Database: ERIC
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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 [adverse events] (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. [The Autism Speaks Autism Clinical Trials Network contributed to the writing of this article.]
ISSN:0162-3257
DOI:10.1007/s10803-019-04120-y