This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Objectives: Once-daily dosing with dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, achieves stable plasma concentrations over 24 hours with once-daily dosing. This study evaluated dasotraline in children aged 6-12-years, meeting DSM-5 criteria for ADHD.
Methods: Patients were randomized 1:1:1 to 6 weeks of once-daily dasotraline (2 or 4 mg/day) or placebo. The primary endpoint was change from baseline (CFB) in ADHD RS-IV HV total score at Week 6 in the ITT population. Secondary outcome measures included CGI-S score and safety endpoints.
Results: Mean age of the 342 randomized patients was 9.1 [±1.9] years; 66.7% were male. 79% of patients completed the study. In the ITT population (N=336), ADHD RS-IV HV total score improved significantly with dasotraline 4 mg/day vs placebo (LS mean CFB at Week 6: -17.53 [95% CI: -20.12, -14.95] vs -11.36 [-13.89, -8.83], respectively, p<0.001; effect size [ES]: 0.48). Improvement in CGI-S score was statistically significant with dasotraline 4 mg/day vs placebo (LS mean CFB at Week 6: -1.39 [-1.63, -1.15] vs -1.04 [-1.28, -0.80], respectively, p=0.040; ES: 0.29). No significant improvement was observed on the ADHD RS-IV HV and the CGI-S for dasotraline 2 mg/day vs placebo. Most frequent TEAEs (_10% and higher than placebo) were (2 mg/day; 4 mg/day; placebo): insomnia (15.3%; 21.7%; 4.3%, all terms combined), and decreased appetite (12.6%; 21.7%; 5.2%).
Conclusions: Compared with placebo, dasotraline 4 mg/day demonstrated statistically significant and clinically meaningful improvement in ADHD symptoms in children and was generally well tolerated.