ArticleJournal of autism and developmental disorders2025
Rosiglitazone Adjunct to Risperidone for Irritability in Autistic Children: A Randomized, Double-Blind, Placebo-Controlled Trial.
Article in Journal of autism and developmental disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
9 authors.
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Abstract
purposeThis randomized, ten-week, double-blind, placebo-controlled clinical trial assessed rosiglitazone, an anti-diabetic agent with neuroprotective and anti-inflammatory effects, for irritability in autism spectrum disorder (ASD).
methods70 participants were allocated to receive either rosiglitazone 2 mg b.i.d. or placebo in addition to risperidone and were evaluated for the Aberrant Behavior Checklist-Community Scale (ABC-C), the Extrapyramidal Symptom Rating Scale, and side effects at baseline and weeks 5 and 10.
resultsThe baseline characteristics were comparable (Ps > 0.05). There were significant time-treatment interaction effects on the irritability subscale ABC-C scores ([Formula: see text] = 0.054). Also, the mean reductions in irritability scores to the endpoint were significantly greater in the rosiglitazone group (Cohen’s d = 0.609). However, the score changes in other subscales were similar between the groups (Ps > 0.05). Using rosiglitazone did not cause significantly different adverse effects.
conclusionRosiglitazone was beneficial for reducing irritability in autistic children in a safe and tolerable manner. The interpretation of these benefits is limited by modest sample size and short duration. CLINICAL
trial registrationThis trial was prospectively registered in the Iranian Registry of Clinical Trials on 2023-04-24 (IRCT20090117001556N150).
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