Evidence map›Paper›PMID 31267292›Full record

Trial reportJournal of autism and developmental disorders2020

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

Paul Herscu, Benjamin L Handen, L Eugene Arnold, Michael F Snape, Joel D Bregman, Lawrence Ginsberg, Robert Hendren, Alexander Kolevzon, Raun Melmed, Mark Mintz and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of autism and developmental disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00515320 (Study Of Fluoxetine In Autism), which is not on this map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00515320 phase3completednot on this map

Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.

TypeinterventionalSponsorNeuropharmRan2007 to 2009Enrolled158ConditionsAutistic DisorderArmsFluoxetine, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Trial
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Pharmacotherapy for the core symptoms of autism spectrum disorder.Journal of Zhejiang University. Science. B · 2024
    Review
  15. Article
  16. Review
  17. Review
  18. [Research progress on long-term developmental outcomes of offspring of pregnant women with systemic lupus erythematosus].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2023
    Article
  19. The Roles of Serotonin in Neuropsychiatric Disorders.Cellular and molecular neurobiology · 2022
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 2 countries.

Paul HerscuHerscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.
Benjamin L HandenSchool of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.
L Eugene ArnoldNisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.
Michael F SnapeNeuropharm PLC, London, UK.
Joel D BregmanCenter for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.
Lawrence GinsbergRed Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.
Robert HendrenUniversity of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.
Alexander KolevzonDepartment 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.
Raun MelmedSouthwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.
Mark MintzThe Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.
Nancy MinshewSchool of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.
Linmarie SikichDuke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.
Ashraf AttallaInstitute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.
Brian KingUCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.
Thomas OwleyUniversity of Illinois at Chicago College of Medicine, 1835 W Polk St, Chicago, IL, USA.
Ann ChildressCenter for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA.
Harry ChuganiNYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA.
Jean FrazierUniversity of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA.
Charles CartwrightSpectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA.
Tanya MurphyUniversity of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA.
Autism Speaks Autism Clinical Trials Network
University of Pittsburgh · USAMO Pharma (United Kingdom) · GBCambridge Health Alliance · USCenter for Autism and Related Disorders · USCenter for Psychiatry and Behavioral Medicine · USChildren's Hospital of Michigan · USIcahn School of Medicine at Mount Sinai · USInstitute for Behavioral Medicine · USNeuroDevelopment Center · USSouthwest Autism Research & Resource Center · USSpectrum Health · USThe Ohio State University · USUniversity of California, Davis · USUniversity of California, San Francisco · USUniversity of Florida · USUniversity of Illinois Chicago · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdolescentAutistic DisorderChildChild, PreschoolDose-Response Relationship, DrugDouble-Blind MethodFemaleFluoxetineHumansMaleSelective Serotonin Reuptake InhibitorsStereotypic Movement DisorderTreatment OutcomeFluoxetineSelective Serotonin Reuptake InhibitorsAutism spectrum disorderRepetitive behaviorSelective seretonin reuptake inhibitor

Identifiers

PMID31267292
OpenAlexW2953462834

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.