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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.
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.
Afiliación
  • Herscu P; Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.
  • Handen BL; Neuropharm PLC, London, UK.
  • Arnold LE; School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.
  • Snape MF; Nisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.
  • Bregman JD; Neuropharm PLC, London, UK.
  • Ginsberg L; AMO Pharma Ltd, Throwsters The Street, Wonersh, GU5 0PF, UK.
  • Hendren R; Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.
  • Kolevzon A; North Shore-Long Island Jewish Health System, New Hyde Park, NY, USA.
  • Melmed R; Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.
  • Mintz M; University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.
  • Minshew N; University of California Davis, Sacramento, CA, USA.
  • Sikich L; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, Seaver Autism Center for Research and Treatment, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1230, New York, NY, USA.
  • Attalla A; Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.
  • King B; The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.
  • Owley T; School of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.
  • Childress A; Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.
  • Chugani H; University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
  • Frazier J; Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.
  • Cartwright C; UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.
  • Murphy T; University of Washington, Seattle, WA, USA.
J Autism Dev Disord ; 50(9): 3233-3244, 2020 Sep.
Article en En | MEDLINE | ID: mdl-31267292
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Autístico / Fluoxetina / Inhibidores Selectivos de la Recaptación de Serotonina / Trastorno de Movimiento Estereotipado Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Autism Dev Disord Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Autístico / Fluoxetina / Inhibidores Selectivos de la Recaptación de Serotonina / Trastorno de Movimiento Estereotipado Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Autism Dev Disord Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos