The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder
| Autor: | Ann Childress, Joel D. Bregman, Harry T. Chugani, Charles Cartwright, Alexander Kolevzon, Jean A. Frazier, Robert L. Hendren, Brian King, Linmarie Sikich, Nancy J. Minshew, Ashraf Attalla, Raun D. Melmed, Snape Michael Frederick, Lawrence D. Ginsberg, Tanya K. Murphy, Mark Mintz, L. Eugene Arnold, Thomas Owley, Paul Herscu, Benjamin L. Handen |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Adolescent Serotonin reuptake inhibitor Stereotypic Movement Disorder Placebo law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Fluoxetine mental disorders Developmental and Educational Psychology medicine Humans 0501 psychology and cognitive sciences Dosing Autistic Disorder Child Dose-Response Relationship Drug 05 social sciences medicine.disease Treatment Outcome Autism spectrum disorder Child Preschool Vomiting Autism Female medicine.symptom Psychology Selective Serotonin Reuptake Inhibitors 030217 neurology & neurosurgery 050104 developmental & child psychology medicine.drug |
| Zdroj: | Journal of Autism and Developmental Disorders. 50:3233-3244 |
| ISSN: | 1573-3432 0162-3257 |
| DOI: | 10.1007/s10803-019-04120-y |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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