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

2015; Elsevier BV; Volume: 170; Linguagem: Inglês

10.1016/j.jpeds.2015.11.033

1097-6833

Diane C. Chugani, Harry T. Chugani, Max Wiznitzer, Sumit Parikh, Patricia Evans, Robin Hansen, Ruth Nass, James Janisse, Pamela Dixon-Thomas, Michael E. 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, R. A. Roeder, Monica Malian, Hailey Turner, Amira Hanna, Jamie Katusin, Deanna Supula, Stacey Halverson, William Guy, Nore Gjolaj, Thomas J. Mangner, Pulak K. Chakraborty, Angela Wigeluk, Gregory Patterson, A Mosqueda, Melissa Styan Burkett, Anna DeBoard, Jane Cornett, Mei-li Lee, Xin Lu, C. Germain, Marianne Majkowski, Beth M. 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, B Calabrò, Carol O. Tacket, Ina Adkins, K H Buchheit, Kathryn Hepper, David Speicher, Susan Bergant, Jennifer Haky, Mary Beth Frohnapfel, Cindy Schaefer, Allison Browning, Roberta Bauer, Rebecca Embacher, Julie Knapp, Stephanie B. Levy, Diane Davies, Donna Lach, John Petrich, Sharon Kreischer, Patty Blubaugh, Mary Ann Morris, Carolyn Garver, Mariam Andersen, Meredith Greene, Amanda Richards, Maria de Fátima Machado Reys Rocha, Ruth Merryman, Sailaja Golla, A. Lorenzen, Julie Long Sherrod, Paulette Perryman, Kara Lorduy, Kathleen Angkustsiri, Lauren B. Plumer, Mary Jacena Leigh, Susan Bacalman, Dorcas L. 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 M. Coffey, Elise Phelps Hanzel, Adriana Campos Passanezi Sant’Ana, Clara Ramirez, Stefanie Berci, Nielsen Gabriel, Glenn A. Hirsch, Elizabeth Roberts, Amanda Zwilling, Resham Gellatly, Dana Levy, Sandi Lee, Jennifer Rodman, Amira Hanna, Nora Oberfield, Susan Friedland, Catherine Lord, Rene Kozloff, Celeste Crouse, Stephanie Millen, Alex J. Coímbre, Kelly McCarter, David J. Posey,

Attention Deficit Hyperactivity Disorder

ObjectivesTo determine safety and efficacy of the 5HT1A serotonin partial agonist buspirone on core autism and associated features in children with autism spectrum disorder (ASD).Study designChildren 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.ResultsThere 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.ConclusionsTreatment 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 registrationClinicalTrials.gov: NCT00873509. To determine safety and efficacy of the 5HT1A serotonin partial agonist buspirone on core autism and associated features in children with autism spectrum disorder (ASD). 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. 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. 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.