TY  - JOUR
PY  - 2020//
TI  - A double-blind, randomized study of extended-release molindone for impulsive aggression in ADHD
JO  - Journal of attention disorders
A1  - Ceresoli-Borroni, Gianpiera
A1  - Nasser, Azmi
A1  - Adewole, Toyin
A1  - Liranso, Tesfaye
A1  - Xu, Jiahong
A1  - Schwabe, Stefan
A1  - Findling, Robert L.
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - <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>
LA  - en
SN  - 1087-0547
UR  - http://dx.doi.org/10.1177/1087054720909084
ID  - ref1
ER  -