OBJECTIVE: To evaluate safety and tolerability of four doses of 
immediate-release molindone hydrochloride in children with 
attention-deficit/hyperactivity disorder (ADHD) and serious conduct problems.
METHODS: This open-label, parallel-group, dose-ranging, multicenter trial 
randomized children, aged 6-12 years, with ADHD and persistent, serious conduct 
problems to receive oral molindone thrice daily for 9-12 weeks in four treatment 
groups: Group 1-10 mg (5 mg if weight <30 kg), group 2-20 mg (10 mg if <30 kg), 
group 3-30 mg (15 mg if <30 kg), and group 4-40 mg (20 mg if <30 kg). The 
primary outcome measure was to evaluate safety and tolerability of molindone in 
children with ADHD and serious conduct problems. Secondary outcome measures 
included change in Nisonger Child Behavior Rating Form-Typical Intelligence 
Quotient (NCBRF-TIQ) Conduct Problem subscale scores, change in Clinical Global 
Impressions-Severity (CGI-S) and -Improvement (CGI-I) subscale scores from 
baseline to end point, and Swanson, Nolan, and Pelham rating scale-revised 
(SNAP-IV) ADHD-related subscale scores.
RESULTS: The study randomized 78 children; 55 completed the study. Treatment 
with molindone was generally well tolerated, with no clinically meaningful 
changes in laboratory or physical examination findings. The most common 
treatment-related adverse events (AEs) included somnolence (n=9), weight 
increase (n=8), akathisia (n=4), sedation (n=4), and abdominal pain (n=4). Mean 
weight increased by 0.54 kg, and mean body mass index by 0.24 kg/m(2). The 
incidence of AEs and treatment-related AEs increased with increasing dose. 
NCBRF-TIQ subscale scores improved in all four treatment groups, with 34%, 34%, 
32%, and 55% decreases from baseline in groups 1, 2, 3, and 4, respectively. 
CGI-S and SNAP-IV scores improved over time in all treatment groups, and CGI-I 
scores improved to the greatest degree in group 4.
CONCLUSIONS: Molindone at doses of 5-20 mg/day (children weighing <30 kg) and 
20-40 mg (≥ 30 kg) was well tolerated, and preliminary efficacy results suggest 
that molindone produces dose-related behavioral improvements over 9-12 weeks. 
Additional double-blind, placebo-controlled trials are needed to further 
investigate molindone in this pediatric population.