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

Published online by Cambridge University Press:  23 March 2020

S.Z. Levine ,
A. Kodesh ,
Y. Goldberg ,
A. Reichenberg ,
T.A. Furukawa ,
A. Kolevzon  and
S. Leucht
S.Z. Levine*
Affiliation:
University of Haifa, Haifa, Israel
A. Kodesh
Affiliation:
University of Haifa, Haifa, Israel
Y. Goldberg
Affiliation:
University of Haifa, Haifa, Israel
A. Reichenberg
Affiliation:
Seaver Autism Center for Research and Treatment, Departments of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, USA
T.A. Furukawa
Affiliation:
Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine, School of Public Health, Kyoto, Japan
A. Kolevzon
Affiliation:
Seaver Autism Center for Research and Treatment, Departments of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, USA
S. Leucht
Affiliation:
Department of Psychiatry and Psychotherapy, Technische Universität München, München, Germany
*
*Corresponding author at: Department of Community Mental Health, University of Haifa, 31905 Haifa, Israel. Tel.: +972 524 896 083; fax: +972 376 173 74. E-mail address: [email protected] (S.Z. Levine).
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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.

Keywords

Clinical trialBaseline severityAutismPsychopharmacologyPlaceboOutcome
Type
Original article
Information
European Psychiatry , Volume 32 , February 2016 , pp. 16 - 20
Copyright
Copyright © European Psychiatric Association 2016

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