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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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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.

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Acknowledgments

This study was funded by Neuropharm Plc. in collaboration with the Autism Speaks Autism Clinical Trials Network. The authors would like to thank all the children and families for their participation in the study.

Author information

Author notes

  1. Deceased—Thomas Owley.

Authors and Affiliations

  1. Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA

    Paul Herscu

  2. Neuropharm PLC, London, UK

    Paul Herscu & Michael F. Snape

  3. School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA

    Benjamin L. Handen

  4. Nisonger Center – UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA

    L. Eugene Arnold

  5. AMO Pharma Ltd, Throwsters The Street, Wonersh, GU5 0PF, UK

    Michael F. Snape

  6. Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA

    Joel D. Bregman

  7. North Shore-Long Island Jewish Health System, New Hyde Park, NY, USA

    Joel D. Bregman

  8. Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA

    Lawrence Ginsberg

  9. University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA

    Robert Hendren

  10. University of California Davis, Sacramento, CA, USA

    Robert Hendren

  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

    Alexander Kolevzon

  12. Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA

    Raun Melmed

  13. The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA

    Mark Mintz

  14. School of Medicine, University of Pittsburgh, 3811 O’Hara St, Pittsburgh, PA, USA

    Nancy Minshew

  15. Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA

    Linmarie Sikich

  16. University of North Carolina Chapel Hill, Chapel Hill, NC, USA

    Linmarie Sikich

  17. Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA

    Ashraf Attalla

  18. UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA

    Brian King

  19. University of Washington, Seattle, WA, USA

    Brian King

  20. University of Illinois at Chicago College of Medicine, 1835 W Polk St, Chicago, IL, USA

    Thomas Owley

  21. Center for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA

    Ann Childress

  22. NYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA

    Harry Chugani

  23. Children’s Hospital of Michigan, Detroit, MI, USA

    Harry Chugani

  24. University of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA

    Jean Frazier

  25. Cambridge Health Alliance, Cambridge, MA, USA

    Jean Frazier

  26. Spectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA

    Charles Cartwright

  27. University of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA

    Tanya Murphy

  28. University of Florida, Gainesville, FL, USA

    Tanya Murphy

Authors
  1. Paul Herscu
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  2. Benjamin L. Handen
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  3. L. Eugene Arnold
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  8. Alexander Kolevzon
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  14. Brian King
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  15. Thomas Owley
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  16. Ann Childress
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  17. Harry Chugani
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  18. Jean Frazier
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  20. Tanya Murphy
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Consortia

the Autism Speaks Autism Clinical Trials Network

Contributions

PH, MS: conceptualization of study, data collection, analyses, manuscript preparation. BH, LA: data collection, analyses, manuscript preparation. JD, LG, RH, AK, RM, MM, NM, LS, AA, BK, TO, AC, HC, JF, CC, TM: Data collection, manuscript preparation. All authors approved the final manuscript.

Corresponding author

Correspondence to Benjamin L. Handen.

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Conflict of interest

Benjamin L. Handen, PhD: Research Funding: Roche, Eli Lilly,Curemark, Eisai Inc, Autism Speaks, NIA, NIMH, NICHD. L. Eugene Arnold, MD: Research Funding, Advisory Boards, Consultation: Forest, Eli Lilly, Noven, Roche, Shire, Supernus, YoungLiving, NIH, Autism Speaks, Pfizer, Tris Pharma, and Waypoint; Arbor, Ironshore, Otsuka, Seaside Therapeutics. Mark Mintz, MD: Research Funding, Advisory Boards, Consultation: Aquestive Therapeutics, Curemark, Eisai Inc., Impax Laboratories, Neurim Pharmaceuticals, Nuvelution Pharma Inc., PhenoSolve, Sunovion, and Teva, NeuroNeeds, Philips-Electrical Geodesics contracted through the Center for Neurological and Neurodevelopmental Health (CNNH NeuroHealth). Expert witness in various litigation and mitigation cases (contracted through CNNH NeuroHealth) and with Philips-Electrical Geodesics (contracted through CNNH NeuroHealth). Dr. Mintz is Chief Medical Officer, Owner and Founder of CNNH and CRCNJ; Board Member of CNNH Management, Inc.; and President and Founder of NeurAbilities, a 501(3)c public charity. Linmarie Sikich, MD: Research Funding, Advisory Boards,: NICHD, Marcus Foundation, Roche, Janssen, Sunovion, Curemark, Neuren Pharmaceuticals. Robert Hendren, DO: Research Funding, Advisory Boards: Curemark, Roche, Shire, Sunovion, BioMarin, Axial Therapeutics, Janssen. Alexander Kolevzon, MD: Research Funding, Consultation: AMO Pharma, Ovid Therapeutics, Sema4, LabCorp, 5AM Ventures, Takeda. Ann Childress, MD: Research Funding, Advisory Boards, Consultation, Speakers Bureau: Lundbeck, Pearson, Alcobra, Arbor, Eli Lilly, Ironshore, Forest Laboratories, Aevi Genomic Medicine, Neos Therapeutics, Neurovance, Otsuka America Pharmaceutical, Pfizer, Purdue, Noven, Shire, Akili, Cingulate, Rhodes, Sunovion, Tris, KemPharm, Supernus, U.S. Food & Drug Administration. Jean Frazier, MD: Research Funding: Roche, Fulcrum Therapeutics, Janssen, Neuren Pharmaceuticals, SyneuRx,NICHD, NIMH, Lawrence Ginsberg, MD: Research Funding, Consultation: Abbott Labs, Hoechst Marrion Roussel, Pfizer, Actavis, Intracellular Therapeutics, Purdue Pharma Canada, Aevi Genomic Medicine, Ironshore Pharmaceuticals, Sanofi-Adventis, Alkermees, Johnson & Johnson, Scherring-Plough, Allergan, Eli Lilly, Seaside Therapeutics, AstraZeneca, McNeil, Sepracor, Axsome Therapeutics, Medgenics, Shinionogi, Biohaven Pharmaceuticals, Neos, Shire, Bristol-Myers-Squibb, Neurocrine Bioscience, Sunovion, Cephalon, Neuropharm Ltd., Supernus, Coronado Biosciences, Novartis Takeda, Cyberonics, Organon Teva, Evidera pharmaceuticals, OrthoMcNeilJansen, UCB Pharma, Finch Therapeutics, Otsuka Maryland Research, Validus, Forest Labs, Pamlab, Wyeth, GSK, Angelini Labopharm, AstraZeneca, Dey, Janssen, Jaymac, Jazz, Lundbeck, Merck, Noven, Otsuka, Pamlab, PGHealth, Sanofi-Aventis, Shionogi, Validus, Wyeth. Michael Shape, PhD; Joel Bergman, MD; Bryan King, MD; Nancy Minshew, MD; Ruan Melmed, MD; Harry Chugani, MD; Charles Cartwright, MD; Ashraf Attalla, MD; and Tanya Murphy, MD, MS have no conflicts of interest to disclose.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and wit the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from the parents/guardians of all individual participants included in the study.

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Herscu, P., Handen, B.L., Arnold, L.E. et al. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord 50, 3233–3244 (2020). https://doi.org/10.1007/s10803-019-04120-y

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