Table 2.
Placebo n=63 | Edivoxetine 0.1 n=58 | Edivoxetine 0.2 n=60 | Edivoxetine 0.3 n=59 | OROS MPHb n=26 | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | Change at end-point | Baseline | Change at end-point | Baseline | Change at end-point | Baseline | Change at end-point | Baseline | Change at end-point | |
ADHD-RS-IV-Parent:Inv | ||||||||||
Total score | 38.0 | −10.4 | 39.9 | −12.2 | 38.1 | −16.1* | 40.2 | −16.4* | 40.1 | −19.5† |
Inattention | 20.7 | −5.6 | 22.8 | −6.2 | 21.8 | −8.6* | 22.0 | −9.1* | 21.9 | −10.5† |
Hyperactivity-Impulsivity | 17.3 | −4.9 | 17.2 | −5.9 | 16.3 | −7.5* | 18.2 | −7.3* | 18.3 | −9.0† |
CGI-ADHD-I | − | 3.1 | − | 3.0 | − | 2.5* | − | 2.5* | − | 2.3 |
CGI-ADHD-S | 4.8 | −1.1 | 4.8 | −1.0 | 4.7 | −1.5* | 4.9 | −1.4 | 4.8 | −1.7 |
CBRS | ||||||||||
Hyperactive-Impulsive | 81.1 | −8.7 | 81.8 | −6.3 | 80.3 | −12.9 | 83.2 | −15.7* | 79.0 | −12.4 |
Inattentive | 80.4 | −10.7 | 81.9 | −8.3 | 80.5 | −11.0 | 82.6 | −17.0* | 85.5 | −18.3 |
Academic difficulty | 70.3 | −6.1 | 72.6 | −6.1 | 71.0 | −5.9 | 72.9 | −12.5* | 74.4 | −12.1 |
Response: CGI-ADHD-I ≤2 (%) | 31.8 | 27.1 | 55.0* | 44.1 | 50.0 | |||||
Response Rate (40% Reduction from baseline in ADHDRS-IV-Parent:Inv score) | 34.9 | 32.8 | 56.7* | 47.5 | 53.9 |
Change scores expressed as least-squares means.
Patients who received OROS MPH were in the stimulant-naïve strata only.
p<0.05 vs. placebo; †p<0.05 vs. the stimulant-naïve placebo group.
0.1=0.1 mg/kg/day; 0.2=0.2 mg/kg/day; 0.3=0.3 mg/kg/day.
ADHD, attention deficit/hyperactivity disorder; ADHD-RS, ADHD rating scale; CBRS, Conners Comprehensive Behavior Rating Scales; CGI-ADHD-I, Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Improvement; CGI-ADHD-S, Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Severity; OROS MPH, osmotic-release oral system methylphenidate.