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A randomized trial of edivoxetine in pediatric patients with attention-deficit/hyperactivity disorder
Daniel Y Lin1, Christopher J Kratochvil, Wen Xu
11 Eli Lilly and Company , Indianapolis, Indiana.
Insights
Edivoxetine, a selective norepinephrine reuptake inhibitor, showed efficacy in treating pediatric attention-deficit/hyperactivity disorder (ADHD) at doses of 0.2 and 0.3 mg/kg/day. The study found no unexpected adverse events, suggesting a potential new treatment option for ADHD.
Area of Science:
- Pharmacology
- Neuroscience
- Pediatric Medicine
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children and adolescents.
- Selective norepinephrine reuptake inhibitors (SNRIs) are a class of drugs used to treat various neurological and psychiatric conditions.
Purpose of the Study:
- To evaluate the efficacy and safety of edivoxetine (LY2216684), an SNRI, in pediatric patients diagnosed with ADHD.
- To compare the effects of different dosages of edivoxetine against placebo and a positive control (methylphenidate).
Main Methods:
- A randomized, double-blind, 8-week study involving 340 pediatric patients (6-17 years) with ADHD.
- Patients were stratified into two groups: those with prior stimulant use and stimulant-naïve patients.
- Treatment arms included placebo, various doses of edivoxetine (0.1, 0.2, 0.3 mg/kg/day), and osmotic-release oral system methylphenidate (OROS MPH) for the stimulant-naïve group.
- The primary efficacy measure was the change in ADHD Rating Scale (ADHD-RS) total score from baseline to week 8.
Main Results:
- Edivoxetine at 0.2 and 0.3 mg/kg/day demonstrated statistically significant improvements in ADHD-RS total scores compared to placebo (p<0.010).
- Both effective doses of edivoxetine also showed significant improvement in Clinical Global Impressions-Improvement scores (p=0.013).
- Edivoxetine treatment was associated with increased blood pressure and pulse, and a slight decrease in weight compared to placebo.
Conclusions:
- Edivoxetine at doses of 0.2 and 0.3 mg/kg/day is effective in treating pediatric ADHD, even with a notable placebo response.
- No unexpected adverse events were identified during the study.
- The findings support edivoxetine as a potential therapeutic option for ADHD in pediatric populations.
Objective:
The purpose of this study was to assess the efficacy and safety of edivoxetine (LY2216684), a selective norepinephrine reuptake inhibitor, in pediatric patients with attention-deficit/hyperactivity disorder (ADHD).
Method:
A fixed-dose, randomized, double-blind, 8 week study was conducted in patients 6-17 years of age, who were randomized by two strata: 1) Patients with prior stimulant use randomized to placebo, edivoxetine 0.1 mg/kg/day, 0.2 mg/kg/day, or 0.3 mg/kg/day arms in a 1:1:1:1 ratio; 2) Stimulant-naïve patients randomized to placebo, edivoxetine 0.1mg/kg/day, 0.2 mg/kg/day, 0.3 mg/kg/day, or osmotic-release oral system methylphenidate (OROS MPH) (18-54 mg/day based on body weight) arms in a 1:1:1:1:1 ratio. The primary efficacy measure was baseline-to-week 8 change of ADHD Rating Scale (ADHD-RS) total score for edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day.
Results:
A total of 340 patients were randomized to placebo (n=78); edivoxetine 0.1 mg/kg/day (n=76), 0.2 mg/kg/day (n=75), or 0.3 mg/kg/day (n=75); or OROS MPH (n=36). In the stimulant-naïve stratum, the positive control, OROS MPH, was significantly superior to placebo in mean ADHD-RS total score change at end-point (-19.46, p=0.015). The edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean ADHD-RS total score change at end-point (placebo -10.35; edivoxetine 0.2 mg/kg/day -16.09, p<0.010; edivoxetine 0.3 mg/kg/day -16.39, p<0.010) and Clinical Global Impressions-Improvement score (placebo 3.05; edivoxetine 0.1 mg/kg/day 3.01, p=0.860; edivoxetine 0.2 mg/kg/day 2.54, p=0.013; edivoxetine 0.3 mg/kg/day 2.53, p=0.013). In the overall efficacy-analyses data set (n=270), the effect size estimates for edivoxetine doses 0.1 mg/kg/day, 0.2 mg/kg/day and 0.3 mg/kg/day at the week 8 time point were 0.17, 0.51, and 0.54, respectively (for the stimulant-naïve stratum, the effect size estimate for OROS MPH was 0.69). Compared with placebo, edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse (p<0.050), and a smaller increase or slight decrease in weight.
Conclusions:
Edivoxetine at doses of 0.2 mg/kg/day and 0.3 mg/kg/day demonstrated efficacy in ADHD treatment, despite the presence of a sizeable placebo response. No unexpected adverse events were identified. Clinical Trial Registry identifier: NCT00922636.
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