@article{ref1,
title="A double-blind, randomized study of extended-release molindone for impulsive aggression in ADHD",
journal="Journal of attention disorders",
year="2020",
author="Ceresoli-Borroni, Gianpiera and Nasser, Azmi and Adewole, Toyin and Liranso, Tesfaye and Xu, Jiahong and Schwabe, Stefan and Findling, Robert L.",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="<b>Objective:</b> To evaluate efficacy and safety of SPN-810 (extended-release molindone) in a Phase-2b, randomized, double-blind, placebo-controlled, dose-ranging study of children (6-12 years) with ADHD and persistent impulsive aggression (IA). <b>Method:</b> After lead-in, children were randomized to (a) placebo (<i>N</i> = 31); (b) low-dose (<i>N</i> = 29, 12/18 mg/day); (c) medium-dose (<i>N</i> = 30, 24/36 mg/day); and (4) high-dose (<i>N</i> = 31, 36/54 mg/day) groups. Treatment included ~2.5-week titration, 3-week maintenance, and 1-week tapering/conversion, alongside existing monotherapy (stimulants/nonstimulants) and behavioral therapy. The primary endpoint was change in Retrospective-Modified Overt Aggression Scale (R-MOAS) score at end of study, with safety monitored. <b>Results:</b> A total of 95 (78.5%) children completed the study. Aggression (R-MOAS) improved with low and medium doses (low dose: <i>p</i> =.031; medium dose: <i>p</i> =.024; high dose: <i>p</i> =.740). The most common adverse events were headache (10.0%), sedation (8.9%), and increased appetite (7.8%). <b>Conclusion:</b> These results suggest SPN-810 may be effective in reducing residual IA behaviors in children with ADHD. Research is still needed to support the benefit-risk profile of SPN-810 in pediatric populations.<p /> <p>Language: en</p>",
language="en",
issn="1087-0547",
doi="10.1177/1087054720909084",
url="http://dx.doi.org/10.1177/1087054720909084"
}