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Design and Subject Characteristics in the Federally-Funded Citalopram Trial in Children with Pervasive Developmental Disorders

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Abstract

The Studies to Advance Autism Research and Treatment Network conducted a randomized trial with citalopram in children with Pervasive developmental disorders (PDDs). We present the rationale, design and sample characteristics of the citalopram trial. Subjects (128 boys, 21 girls) had a mean age of 9.3 (±3.12) years; 132 (88.6%) were diagnosed with autistic disorder (4.7% with Asperger’s Disorder; 6.7% with PDD-not otherwise specified). Less than half of the subjects were intellectually disabled; 117 (78.5%) were rated Moderate or Marked on the Clinical Global Impression for Severity. Study measures were similar to previous Research Units on Pediatric Psychopharmacology trials. Subjects in this trial were slightly older and more likely to have complaints of repetitive behavior than participants in RUPP trials.

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Acknowledgments

This work was funded by National Institutes of Health via the following Studies to Advance Autism Research and Treatment (STAART) center contracts: Boston Univ/Dartmouth- U54-MH066398, Helen Tager-Flusberg, PI; DM-STAT–U01-HD045023, Kimberly Dukes, PI;Mt Sinai–U54–MH066673, Eric Hollander, PI; UCLA–U54-MH068172, Marian Sigman, PI; UNC–U54-MH066418, Joseph Piven, PI; Yale–U54-MH066494, Fred Volkmar, PI; Yale Research Unit on Pediatric Psychopharmacology (RUPP)–U10MH66764, Lawrence Scahill, PI and the CTSA Grant UL1 RR024139 from the National Center for Research Resources (NCRR) to Yale University. The STAART Psychopharmacology Network included the work of Rosemary Affeldt, M.S.W., L.I.C.S.W., Denisse Ambler, M.D., George Anderson, Ph.D., May-Lynn Andresen, R.N., Grace Baranek, Ph.D., Jennifer Bartz, Ph.D., Terrence C. Bethea, M.D., Jennifer Cowen, M.A., Pegeen Cronin, Ph.D., Margaret DeRamus, B.A., Robert Dimino, Ph.D., Tywanda Ellison, Ph.D., Nicole Feirsen, B.A., Lilia Fenelon, B.A., Anita Gordon, M.S.W., Danielle Halpern, Ph.D., Marisa B. Houser, M.S., Cathy Jones, B.A., Lawrence Kaplan, M.D., Paul Kartheiser, M.D., Robyn Keske, M.S.W., M.P.H., Young Shin Kim, M.D., Ph.D., Kathy Koenig, M.S.N., Erin Kustan, B.A., Kathleen Lapp, M.D., Arthur Maerlender, Ph.D., Brenna McDonald, Psy.D., M.B.A., Debra McQuade, Ph.D., M.D., Shana Nichols, Ph.D., Roumen Nikolov, M.D., Maryellen Pachler, M.S.N., Emily Quinn, M.A., Idania Ramirez, M.P.H., Jennifer Richards, M.D., Peter Robichaux, B.A., Jade Rusoff, B.A., Bhavik Shah, M.D., Latha Soorya, Ph.D., Linda Spritzer, B.A., Erika Swanson, B.A., Tara Tripp, M.A., John Vidaver, M.A., Shulamit Waldoks, B.A., A. Ting Wang, Ph.D., Stacey Wasserman, M.D., Emily Williams, M.Ed.

Conflict of interest

Dr. Donnelly has served as a consultant for Eli Lilly Pharmaceutical Company, Abbott Pharmaceutical Company and Impax Pharmaceuticals. He has served on the Speaker’s Bureau for Eli Lilly, Janssen and Shire. He has received research funding from Eli Lilly. Dr. Hollander reports serving as a consultant to Neuropharm. Dr. King reports serving as a consultant to Biomarin and Neuropharm and as an unpaid consultant to Forest, Nastech, and Seaside Therapeutics. He has received or has pending research grant support from Neuropharm to Seaside Therapeutics. Dr. McCracken has served as a consultant for Abbott, Eli Lilly, Janssen, Johnson & Johnson, McNeil, Novartis, Wyeth, Shire, and Sanofi-Aventis. He has received research grant support from Bristol Myers Squibb, Eli Lilly, McNeil, Pfizer, Shire, Johnson & Johnson, and Aspect. He has served on the Speaker’s Bureau for UCB and Eli Lilly. Dr. Scahill has served as a consultant to Boheringer-Ingleheim, Pfizer, Hoffman, and NeuroSearch and has received research grant support from Seaside and Shire. Dr. Sikich has received support from Bristol Myers Squibb and Pfizer, participated in clinical trials sponsored by Neuropharm, Curemark, Seaside Pharmaceuticals, and recieved medications or software Janssen Pharmaceutica, Eli Lilly, Pfizer, Bristol Myers Squibb and Positscience. Dr. Anagnostou has consulted without fee to Neuropharm and Proximagen. Drs Bearss, Bregman, Dukes, Hirtz, Kim, Robinson, Sullivan, Wagner, and Ms. Ritz have no conflicts to disclose.

Author information

Author notes

  1. Eric Hollander

    Present address: Albert Einstein College of Medicine and Montefiore Medical Center, New York, NY, USA

  2. Bryan King

    Present address: University of Washington & Seattle Children’s Hospital, Seattle, WA, USA

  3. Joel Bregman

    Present address: University of Missouri, Columbia, MO, USA

  4. Evdokia Anagnostou

    Present address: Bloorview Research Institute, University of Toronto, Toronto, Canada

  5. Louise Ritz

    Present address: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA

Authors and Affiliations

  1. Yale University School of Nursing and Child Study Center, 230 S. Frontage Rd., New Haven, CT, USA

    Lawrence Scahill & Karen Bearss

  2. University of California, Los Angeles, CA, USA

    James T. McCracken

  3. DM STAT, Boston, MA, USA

    Fay Robinson & Kimberly Dukes

  4. Mt. Sinai Medical School, New York, NY, USA

    Eric Hollander & Evdokia Anagnostou

  5. Dartmouth Medical School, Hanover, NH, USA

    Bryan King & Craig Donnelly

  6. North Shore Long Island Jewish Health System, Manhasset, NY, USA

    Joel Bregman

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

    Lin Sikich

  8. Boston University, Boston, MA, USA

    Lisa Sullivan

  9. Yale University, New Haven, CT, USA

    Young-Shin Kim

  10. National Institute of Mental Health, Bethesda, MD, USA

    Louise Ritz & Ann Wagner

  11. National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA

    Deborah Hirtz

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Correspondence to Lawrence Scahill.

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The opinions and assertions contained in this report are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of Health and Human Services, the National Institutes of Health, the National Institute of Mental Health, the National Institute of Child Health and Development, or the National Institute of Neurological Disease and Stroke.

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Scahill, L., McCracken, J.T., Bearss, K. et al. Design and Subject Characteristics in the Federally-Funded Citalopram Trial in Children with Pervasive Developmental Disorders. J Autism Dev Disord 42, 432–440 (2012). https://doi.org/10.1007/s10803-011-1251-8

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  • DOI: https://doi.org/10.1007/s10803-011-1251-8

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