A Double-Blind, Randomized Study of Extended-Release Molindone for Impulsive Aggression in ADHD. Issue 11 (September 2021)

• Record Type: Journal Article
• Authors: Ceresoli-Borroni, Gianpiera; Nasser, Azmi; Adewole, Toyin; Liranso, Tesfaye; Xu, Jiahong; Schwabe, Stefan; Findling, Robert L.
• Is Part Of: Journal of attention disorders. Volume 25:Issue 11(2021)
• Page Start: 1564
• Page End: 1577
• Publication Date: 2021-09
• Subjects: molindone -- impulsive aggression -- stimulants -- attention-deficit/hyperactivity disorder -- maladaptive aggression; Attention-deficit hyperactivity disorder -- Periodicals; Attention -- Periodicals; 616.8589
• DOI: 10.1177/1087054720909084
• Languages: English
• ISSNs: 1087-0547

Abstract

Objective: 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).Method: After lead-in, children were randomized to (a) placebo ( N = 31); (b) low-dose ( N = 29, 12/18 mg/day); (c) medium-dose ( N = 30, 24/36 mg/day); and (4) high-dose ( N = 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.Results: A total of 95 (78.5%) children completed the study. Aggression (R-MOAS) improved with low and medium doses (low dose: p = .031; medium dose: p = .024; high dose: p = .740). The most common adverse events were headache (10.0%), sedation (8.9%), and increased appetite (7.8%).Conclusion: 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.