NDLI: Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.

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Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.

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Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Levine, S. Z. Kodesh, A. Goldberg, Y. Reichenberg, A. Furukawa, T. A. Kolevzon, A. Leucht, S.
Description	Author Affiliation: Levine SZ ( University of Haifa, Haifa, Israel. Electronic address: slevine@univ.haifa.ac.il.); Kodesh A ( University of Haifa, Haifa, Israel.); Goldberg Y ( University of Haifa, Haifa, Israel.); Reichenberg A ( Seaver Autism Center for Research and Treatment, Departments of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, USA.); Furukawa TA ( Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine, School of Public Health, Kyoto, Japan.); Kolevzon A ( Seaver Autism Center for Research and Treatment, Departments of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, USA.); Leucht S ( Department of Psychiatry and Psychotherapy, Technische Universität München, München, Germany.)
Abstract	BACKGROUND: Risperidone is a common psychopharmacological treatment for irritability in autism spectrum disorder (ASD). It is not well-established how effective risperidone is across the initial symptom severity range. This study aims to examine the influence of baseline severity on the efficacy of risperidone in the treatment of ASD. METHODS: Participants were from the NIMH funded RUPP multisite, randomized, double-blind trial that compared risperidone to placebo to treat autistic disorder with severe tantrums, aggression, or self-injury. Participants were aged 5 to 17, and randomly assigned to risperidone (n=49) or placebo (n=52). Baseline and change scores were computed with the Aberrant Behavior Checklist (ABC) parent assessed scales with irritability as the primary outcome, as well as the clinician assessed ABC Irritability subscale, and Clinical Global Impression Scale. RESULTS: The relationship between baseline severity and change scores for the risperdone and placebo groups was examined with eight competing three-level mixed-effects models for repeated measure models. Significant (P<0.01) interactions between treatment and baseline severity were observed for parent ABC ratings of irritability and lethargy only. Greater magnitudes of the differences between risperidone and placebo were observed from moderate to very severe baseline severity on irritability and lethargy. Initial severity values over approximately 30 had a strong effect on symptom change [irritability: effect size (ES)=1.9, number needed to treat (NNT)=2, lethargy ES=0.9, NNT=5]. CONCLUSIONS: Parents may expect benefits of risperidone on irritability and lethargy with moderate to severe symptoms of ASD. TRIAL REGISTRATION: Registry name: ClinicalTrials.gov, trial identifier: NCT00005014, URL: http://www.clinicaltrials.gov/ct2/show/NCT00005014?term=NCT00005014&rank=1, registered on March 31, 2000.
File Format	HTM / HTML
ISSN	09249338
Volume Number	32
e-ISSN	17783585
Journal	European Psychiatry
Language	English
Publisher	Elsevier
Publisher Date	2016-02-01
Publisher Place	France
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Psychiatry Autistic Disorder Drug Therapy Risperidone Adolescent Aggression Drug Effects Antipsychotic Agents Administration & Dosage Adverse Effects Diagnosis Psychology Child Child, Preschool Double-blind Method Drug Monitoring Female Humans Irritable Mood Male Self-injurious Behavior Treatment Outcome Journal Article Randomized Controlled Trial Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Psychiatry and Mental Health

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