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

Paul Herscu^{1

2}, Benjamin L Handen³, L Eugene Arnold⁴, Michael F Snape^{2

5}, Joel D Bregman^{6

7}, Lawrence Ginsberg⁸, Robert Hendren^{9

10}, Alexander Kolevzon¹¹, Raun Melmed¹², Mark Mintz¹³, Nancy Minshew¹⁴, Linmarie Sikich^{15

16}, Ashraf Attalla¹⁷, Brian King^{18

19}, Thomas Owley²⁰, Ann Childress²¹, Harry Chugani^{22

23}, Jean Frazier^{24

25}, Charles Cartwright²⁶, Tanya Murphy^{27

28}; Autism Speaks Autism Clinical Trials Network

Affiliations

¹ Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.
² Neuropharm PLC, London, UK.
³ School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.
⁴ Nisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.
⁵ AMO Pharma Ltd, Throwsters The Street, Wonersh, GU5 0PF, UK.
⁶ Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.
⁷ North Shore-Long Island Jewish Health System, New Hyde Park, NY, USA.
⁸ Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.
⁹ University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.
¹⁰ University of California Davis, Sacramento, CA, USA.
¹¹ 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.
¹² Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.
¹³ The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.
¹⁴ School of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.
¹⁵ Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.
¹⁶ University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
¹⁷ Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.
¹⁸ UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.
¹⁹ University of Washington, Seattle, WA, USA.
²⁰ University of Illinois at Chicago College of Medicine, 1835 W Polk St, Chicago, IL, USA.
²¹ Center for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA.
²² NYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA.
²³ Children's Hospital of Michigan, Detroit, MI, USA.
²⁴ University of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA.
²⁵ Cambridge Health Alliance, Cambridge, MA, USA.
²⁶ Spectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA.
²⁷ University of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA.
²⁸ University of Florida, Gainesville, FL, USA.

PMID: 31267292
DOI: 10.1007/s10803-019-04120-y

Clinical Trial

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

Paul Herscu et al. J Autism Dev Disord. 2020 Sep.

. 2020 Sep;50(9):3233-3244.

doi: 10.1007/s10803-019-04120-y.

Authors

Affiliations

¹ Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.
² Neuropharm PLC, London, UK.
³ School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.
⁴ Nisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.
⁵ AMO Pharma Ltd, Throwsters The Street, Wonersh, GU5 0PF, UK.
⁶ Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.
⁷ North Shore-Long Island Jewish Health System, New Hyde Park, NY, USA.
⁸ Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.
⁹ University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.
¹⁰ University of California Davis, Sacramento, CA, USA.
¹¹ 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.
¹² Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.
¹³ The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.
¹⁴ School of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.
¹⁵ Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.
¹⁶ University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
¹⁷ Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.
¹⁸ UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.
¹⁹ University of Washington, Seattle, WA, USA.
²⁰ University of Illinois at Chicago College of Medicine, 1835 W Polk St, Chicago, IL, USA.
²¹ Center for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA.
²² NYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA.
²³ Children's Hospital of Michigan, Detroit, MI, USA.
²⁴ University of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA.
²⁵ Cambridge Health Alliance, Cambridge, MA, USA.
²⁶ Spectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA.
²⁷ University of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA.
²⁸ University of Florida, Gainesville, FL, USA.

PMID: 31267292
DOI: 10.1007/s10803-019-04120-y

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.

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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

Affiliations

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

Authors

Affiliations

Abstract

Publication types

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Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical