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A Double-Blind, Randomized Study of Extended-Release Molindone for Impulsive Aggression in ADHD.

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.
AuthorsGianpiera Ceresoli-Borroni, Azmi Nasser, Toyin Adewole, Tesfaye Liranso, Jiahong Xu, Stefan Schwabe, Robert L Findling
JournalJournal of attention disorders (J Atten Disord) Vol. 25 Issue 11 Pg. 1564-1577 (09 2021) ISSN: 1557-1246 [Electronic] United States
PMID32338106 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Central Nervous System Stimulants
  • Delayed-Action Preparations
  • Molindone
Topics
  • Aggression
  • Attention Deficit Disorder with Hyperactivity (drug therapy)
  • Central Nervous System Stimulants (therapeutic use)
  • Child
  • Delayed-Action Preparations (therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Humans
  • Molindone (therapeutic use)
  • Retrospective Studies
  • Treatment Outcome

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