Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder: A Randomized Trial - 25/02/16

Doi : 10.1016/j.jpeds.2015.11.033

Diane C. Chugani, PhD ^1,^2,^⁎ , Harry T. Chugani, MD ^1,^2,³, Max Wiznitzer, MD ⁴, Sumit Parikh, MD ⁵, Patricia A. Evans, MD, PhD ⁶, Robin L. Hansen, MD ⁷, Ruth Nass, MD ^8,⁹, James J. Janisse, PhD ¹⁰, Pamela Dixon-Thomas, PhD ¹, Michael Behen, PhD ^1,², Robert Rothermel, PhD ¹¹, Jacqueline S. Parker, BSc ^1,², Ajay Kumar, MD, PhD ^1,^2,^3,¹², Otto Muzik, PhD ^1,^2,^3,¹², David J. Edwards, PharmD ¹³, Deborah Hirtz, MD ¹⁴
on behalf of the
Autism Center of Excellence Network^{^∗}
List of members of the Autism Center of Excellent Network is available at www.jpeds.com (Appendix).
Huiyuan Jiang, MD, Lalitha Sivaswamy, MD, Ginger Steinhilber, RN, Kristin Kennedy, RN, Kathy Pawlik, CNP, Ruth Roeder, PNP, Monica Malian, Hailey Turner, Amira Hanna, Jamie Katusin, Deanna Supula, RN, Stacey Halverson, William Guy, Nore Gjolaj, Thomas Mangner, PhD, Pulak Chakraborty, PhD, Angela Wigeluk, Gregory Patterson, Andrew Mosqueda, Melissa Burkett, Anna DeBoard, RN, Jane Cornett, RN, Mei-li Lee, Xin Lu, Catherine Germain, Marianne Majkowski, DO, Beth French, PNP, Amy Stolinski, Suzi Naguib, PhD, Courtney Wolfe-Christensen, PhD, Sara Taylor, Jamal Ameli, Julie Kemp McQueeney, Michelle Rubinlicht, Bethany Gorka, Erin Zacharski, Jeffrey L. Blumer, PhD, MD, Kathleen Maxwell, RN, Catherine Tasi, RN, Philip Toltzis, MD, Jolee Kalic, RN, Dianne Morus, RRT, Jany Paulett, Bonnie Rosolowski, RRT, Michael Banchy, RPh, Kathryn Westlake, RPh, Barbara Calabro, CCRP, Carol Tacket, CCRP, Ina Adkins, RN, Kenneth Buchheit, RN, Kathryn Hepper, RN, David Speicher, MD, Susan Bergant, RN, Jennifer Haky, Mary Beth Frohnapfel, RN, Cindy Schaefer, RN, Allison Browning, Roberta Bauer, MD, Rebecca Embacher, Julie Knapp, PhD, Stephanie Levy, Diane Davies, Donna Lach, John Petrich, Rph, MS, Sharon Kreischer, Patty Blubaugh, Mary Ann Morris, Carolyn Garver, Mariam Andersen, Meredith Greene, Amanda Richards, Maria Rocha, Ruth Merryman, Sailaja Golla, MD, Alan Lorenzen, Julie Long Sherrod, Paulette Perryman, Kara Lorduy, Kathleen Angkustsiri, MD, Lauren Back Plumer, MD, Mary Jacena Siy Leigh, MD, Susan C. Bacalman, MSW, MD, Dorcas Liriano Roa, PhD, Kushma Govindappa, MD, Gayatri Mahajan, MD, Erika Bickel, Norman Brule, Emma Hare, Nadir Sarwary, Dominique Cargill, Joyce Lee, Smiley Hom, Dennis Steindorf, Mandy Pietrykowski, Kindra Root, Sarah Coffey, Elise Phelps Hanzel, PhD, Adriana Santana, Clara Ramirez, Stefanie Berci, Nielsen Gabriel, Glenn Hirsch, MD, Elizabeth Roberts, PsyD, Amanda Zwilling, Resham Gellatly, Dana Levy, PsyD, Sandi Lee, RPh, Jennifer Rodman, Amira Hanna, Nora Oberfield, Susan Friedland, Catherine Lord, PhD, Rene Kozloff, RN, PhD, Celeste Crouse, Stephanie Millen, Alex J. Coímbre, BA, MPS, CCRA, Kelly L. McCarter, MA, LPC MHSP, David Posey, MD

¹ Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI
² Children's Hospital of Michigan, Detroit, MI
³ Department of Neurology, Wayne State University School of Medicine, Detroit, MI
⁴ Neuroscience Institute, University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital, Cleveland, OH
⁵ Cleveland Clinic Neurogenetics & Metabolism, Neuroscience Institute Lerner College of Medicine-Case Western Reserve University, Cleveland, OH
⁶ Departments of Neurology and Pediatrics, University of Texas Southwestern Medical Center, Children's Medical Center of Dallas, Dallas, TX
⁷ Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, Department of Pediatrics, University of California Davis, Davis, CA
⁸ Department of Neurology, New York University Langone Medical Center, New York, NY
⁹ Department of Child and Adolescent Psychiatry, New York University Langone Medical Center, New York, NY
¹⁰ Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, MI
¹¹ Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, MI
¹² Department of Radiology, Wayne State University School of Medicine, Detroit, MI
¹³ School of Pharmacy, University of Waterloo, Waterloo, Ontario, Canada
¹⁴ National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD

^∗Reprint requests: Diane C. Chugani, PhD, Nemours—AI DuPont Hospital for Children, 1600 Rockland Road, ARB 291, Wilmington, DE 19803.Division of Clinical Pharmacology and ToxicologyChildren's Hospital of Michigan3901 Beaubien Blvd.Room 3N47DetroitMI48201

Abstract

Objectives

To determine safety and efficacy of the 5HT_1A serotonin partial agonist buspirone on core autism and associated features in children with autism spectrum disorder (ASD).

Study design

Children 2-6 years of age with ASD (N = 166) were randomized to receive placebo or 2.5 or 5.0 mg of buspirone twice daily. The primary objective was to evaluate the effects of 24 weeks of buspirone on the Autism Diagnostic Observation Schedule (ADOS) Composite Total Score. Secondary objectives included evaluating the effects of buspirone on social competence, repetitive behaviors, language, sensory dysfunction, and anxiety and to assess side effects. Positron emission tomography measures of tryptophan metabolism and blood serotonin concentrations were assessed as predictors of buspirone efficacy.

Results

There was no difference in the ADOS Composite Total Score between baseline and 24 weeks among the 3 treatment groups (P = .400); however, the ADOS Restricted and Repetitive Behavior score showed a time-by-treatment effect (P = .006); the 2.5-mg buspirone group showed significant improvement (P = .003), whereas placebo and 5.0-mg buspirone groups showed no change. Children in the 2.5-mg buspirone group were more likely to improve if they had fewer foci of increased brain tryptophan metabolism on positron emission tomography (P = .018) or if they showed normal levels of blood serotonin (P = .044). Adverse events did not differ significantly among treatment groups.

Conclusions

Treatment with 2.5 mg of buspirone in young children with ASD might be a useful adjunct therapy to target restrictive and repetitive behaviors in conjunction with behavioral interventions.

Trial registration

ClinicalTrials.gov: NCT00873509.

Le texte complet de cet article est disponible en PDF.

Keyword : 1-PP, ABC, ADI-R, ADOS, ADOS-CTS, ADOS-RRB, ADOS-SA, AMT, ASD, PET, RBS, SUV

Plan

Methods

Treatment

Efficacy Measures

PET Scan Protocol and Image Data Analyses

Adverse Events and Laboratory Measures

Supported by the National Institute of Neurological Disorders and Stroke (cooperative agreement 5U01 NS61264). The authors declare no conflicts of interest.

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Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder: A Randomized Trial - 25/02/16

Abstract

Objectives

Study design

Results

Conclusions

Trial registration

Plan

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