Initial severity and efficacy of risperidone in autism: Results from the RUPP trial
| Autor: | Stefan Leucht, Yair Goldberg, Alexander Kolevzon, Stephen Z. Levine, Arad Kodesh, Avi Reichenberg, Toshi A. Furukawa |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Pediatrics Adolescent Irritability Placebo 03 medical and health sciences Lethargy 0302 clinical medicine Double-Blind Method 030225 pediatrics medicine Humans Autistic Disorder Child Psychiatry Risperidone Repeated measures design medicine.disease Irritable Mood Aggression Psychiatry and Mental health Treatment Outcome Autism spectrum disorder Child Preschool Clinical Global Impression Autism Female Drug Monitoring medicine.symptom Psychology Self-Injurious Behavior 030217 neurology & neurosurgery Antipsychotic Agents medicine.drug |
| Zdroj: | European Psychiatry. 32:16-20 |
| ISSN: | 1778-3585 0924-9338 |
| DOI: | 10.1016/j.eurpsy.2015.11.004 |
| Popis: | BackgroundRisperidone 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.MethodsParticipants 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.ResultsThe 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].ConclusionsParents may expect benefits of risperidone on irritability and lethargy with moderate to severe symptoms of ASD.Trial registrationRegistry name: ClinicalTrials.gov, trial identifier: NCT00005014, URL: http://www.clinicaltrials.gov/ct2/show/NCT00005014?term=NCT00005014&rank=1, registered on March 31, 2000. |
| Databáze: | OpenAIRE |
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