1. Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder: A Randomized Trial
- Author
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Diane C. Chugani, Harry T. Chugani, Max Wiznitzer, Sumit Parikh, Patricia A. Evans, Robin L. Hansen, Ruth Nass, James J. Janisse, Pamela Dixon-Thomas, Michael Behen, Robert Rothermel, Jacqueline S. Parker, Ajay Kumar, Otto Muzik, David J. Edwards, Deborah Hirtz, Huiyuan Jiang, Lalitha Sivaswamy, Ginger Steinhilber, Kristin Kennedy, Kathy Pawlik, Ruth Roeder, Monica Malian, Hailey Turner, Amira Hanna, Jamie Katusin, Deanna Supula, Stacey Halverson, William Guy, Nore Gjolaj, Thomas Mangner, Pulak Chakraborty, Angela Wigeluk, Gregory Patterson, Andrew Mosqueda, Melissa Burkett, Anna DeBoard, Jane Cornett, Mei-li Lee, Xin Lu, Catherine Germain, Marianne Majkowski, Beth French, Amy Stolinski, Suzi Naguib, Courtney Wolfe-Christensen, Sara Taylor, Jamal Ameli, Julie Kemp McQueeney, Michelle Rubinlicht, Bethany Gorka, Erin Zacharski, Jeffrey L. Blumer, Kathleen Maxwell, Catherine Tasi, Philip Toltzis, Jolee Kalic, Dianne Morus, Jany Paulett, Bonnie Rosolowski, Michael Banchy, Kathryn Westlake, Barbara Calabro, Carol Tacket, Ina Adkins, Kenneth Buchheit, Kathryn Hepper, David Speicher, Susan Bergant, Jennifer Haky, Mary Beth Frohnapfel, Cindy Schaefer, Allison Browning, Roberta Bauer, Rebecca Embacher, Julie Knapp, Stephanie Levy, Diane Davies, Donna Lach, John Petrich, Sharon Kreischer, Patty Blubaugh, Mary Ann Morris, Carolyn Garver, Mariam Andersen, Meredith Greene, Amanda Richards, Maria Rocha, Ruth Merryman, Sailaja Golla, Alan Lorenzen, Julie Long Sherrod, Paulette Perryman, Kara Lorduy, Kathleen Angkustsiri, Lauren Back Plumer, Mary Jacena Siy Leigh, Susan C. Bacalman, Dorcas Liriano Roa, Kushma Govindappa, Gayatri Mahajan, 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, Adriana Santana, Clara Ramirez, Stefanie Berci, Nielsen Gabriel, Glenn Hirsch, Elizabeth Roberts, Amanda Zwilling, Resham Gellatly, Dana Levy, Sandi Lee, Jennifer Rodman, Nora Oberfield, Susan Friedland, Catherine Lord, Rene Kozloff, Celeste Crouse, Stephanie Millen, Alex J. Coímbre, Kelly L. McCarter, and David Posey
- Subjects
Male ,medicine.medical_specialty ,Serotonin ,Autism Spectrum Disorder ,Placebo ,Partial agonist ,Autism Diagnostic Observation Schedule ,Buspirone ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Child Development ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Pediatrics, Perinatology, and Child Health ,Psychiatry ,Child ,business.industry ,medicine.disease ,030227 psychiatry ,3. Good health ,Serotonin Receptor Agonists ,Treatment Outcome ,Autism spectrum disorder ,Child, Preschool ,Positron-Emission Tomography ,Pediatrics, Perinatology and Child Health ,Autism ,Anxiety ,Female ,medicine.symptom ,business ,030217 neurology & neurosurgery ,medicine.drug - 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.
- Published
- 2016
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