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Purpose <p>This 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).</p> Methods <p>70 participants were allocated to receive either rosiglitazone 2&#xa0;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.</p> Results <p>The baseline characteristics were comparable (<i>P</i>s &gt; 0.05). There were significant time-treatment interaction effects on the irritability subscale ABC-C scores (<InlineEquation ID="IEq1"> <EquationSource Format="TEX">\(\:{{\upeta\:}}_{P}^{2}\)</EquationSource> </InlineEquation> = 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 (<i>P</i>s &gt; 0.05). Using rosiglitazone did not cause significantly different adverse effects.</p> Conclusion <p>Rosiglitazone 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.</p> Clinical Trial Registration <p>This trial was prospectively registered in the Iranian Registry of Clinical Trials on 2023-04-24 (IRCT20090117001556N150).</p>

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Rosiglitazone Adjunct to Risperidone for Irritability in Autistic Children: A Randomized, Double-Blind, Placebo-Controlled Trial

  • 期刊论文

  • 发表日期：

    2025年12月26日

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  • Nikoo Bayan,
  • Negar Bayan,
  • Faezeh Mokhtari,
  • Ahmad Shamabadi,
  • Alireza Hasanzadeh,
  • Mahdi Hasanzadeh,
  • Ariana Karkhaneh-Yousefi,
  • Mohammadreza Mohammadi,
  • Shahin Akhondzadeh

摘要

Purpose

This 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).

Methods

70 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.

Results

The baseline characteristics were comparable (Ps > 0.05). There were significant time-treatment interaction effects on the irritability subscale ABC-C scores ( \(\:{{\upeta\:}}_{P}^{2}\) = 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.

Conclusion

Rosiglitazone 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 Registration

This trial was prospectively registered in the Iranian Registry of Clinical Trials on 2023-04-24 (IRCT20090117001556N150).