Table 2.
Symptom Change from Baseline (Pretitration) to Postbaseline (End Treatment) (Intent-To-Treat Population)
| |
ORADUR®-MPH (N = 99) |
Placebo (N = 99) |
Group differences |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
Baseline |
Endpoint |
Endpoint–baseline |
Baseline |
Endpoint |
Endpoint–baseline |
Endpoint |
Endpoint–baseline |
||||||
| Mean, M (SD) | M (SD) | M (SD) | M (SD) | Cohen's d | p | M (SD) | M (SD) | M (SD) | Cohen's d | p | Cohen's d | p | Cohen's d | p |
| SNAP-IV—Teacher Form | ||||||||||||||
| Inattention | 15.3 (6.4) | 10.5 (6.6) | −4.6 (5.2) | −0.74 | <0.0001 | 15.4 (6.5) | 11.4 (6.6) | −4.0 (5.0) | −0.61 | <0.0001 | −0.14 | 0.032 | −0.12 | 0.045 |
| Hyperactive/impulsivity | 10.4 (8.1) | 7.3 (6.9) | −2.7 (5.1) | −0.41 | <0.0001 | 10.5 (8.1) | 8.5 (7.3) | −1.8 (4.9) | −0.26 | 0.0004 | −0.17 | 0.003 | −0.18 | 0.005 |
| Oppositional defiant | 7.1 (7.1) | 4.3 (5.8) | −2.7 (5.1) | −0.43 | <0.0001 | 7.2 (7.2) | 5.1 (6.2) | −1.9 (4.5) | −0.31 | 0.0001 | −0.13 | 0.081 | −0.17 | 0.067 |
| Total score | 32.8 (19.2) | 22.1 (17.3) | −10.0 (13.0) | −0.59 | <0.0001 | 33.1 (19.4) | 25.0 (17.9) | −7.7 (11.7) | −0.43 | <0.0001 | −0.16 | 0.005 | −0.19 | 0.006 |
| SNAP-IV–Parent Form | ||||||||||||||
| Inattention | 16.8 (4.7) | 9.8 (4.1) | −6.9 (5.0) | −1.59 | <0.0001 | 16.9 (4.6) | 11.1 (5.2) | −5.8 (5.0) | −1.18 | <0.0001 | −0.28 | 0.004 | −0.22 | 0.005 |
| Hyperactive/impulsivity | 12.5 (6.1) | 7.6 (5.2) | −4.9 (4.7) | −0.86 | <0.0001 | 12.5 (6.1) | 8.3 (6.0) | −4.1 (4.1) | −0.69 | <0.0001 | −0.12 | 0.037 | −0.18 | 0.035 |
| Oppositional defiant | 10.5 (5.7) | 6.1 (4.5) | −4.4 (5.0) | −0.86 | <0.0001 | 10.6 (5.7) | 6.4 (5.0) | −4.2 (4.3) | −0.78 | <0.0001 | −0.06 | 0.612 | −0.04 | 0.657 |
| Total score | 39.7 (13.1) | 23.5 (11.5) | −16.2 (11.8) | −1.31 | <0.0001 | 39.9 (13.1) | 25.8 (14.0) | −14.1 (11.0) | −1.04 | <0.0001 | −0.18 | 0.021 | −0.18 | 0.024 |
| CTRS-R:S | ||||||||||||||
| Inattention score | 9.0 (6.0) | 6.3 (5.5) | −2.3 (3.5) | −0.47 | <0.0001 | 9.0 (6.0) | 7.3 (6.0) | −1.6 (3.8) | −0.28 | 0.0001 | −0.17 | 0.039 | −0.19 | 0.043 |
| Hyperactivity score | 10.2 (4.8) | 6.8 (4.7) | −3.2 (3.5) | −0.72 | <0.0001 | 10.3 (4.8) | 7.8 (5.0) | −2.5 (3.4) | −0.51 | <0.0001 | −0.21 | 0.015 | −0.20 | 0.014 |
| Oppositional score | 8.6 (6.1) | 5.7 (5.4) | −2.5 (4.1) | −0.50 | <0.0001 | 8.6 (6.1) | 6.6 (5.6) | −1.9 (4.1) | −0.34 | <0.0001 | −0.16 | 0.089 | −0.15 | 0.109 |
| ADHD index score | 12.0 (7.1) | 8.1 (6.5) | −3.6 (4.5) | −0.57 | <0.0001 | 12.0 (7.1) | 9.3 (6.8) | −2.6 (4.3) | −0.39 | <0.0001 | −0.18 | 0.010 | −0.23 | 0.010 |
| CGI-ADHD-S | 4.9 (1.1) | 3.3 (1.0) | −1.6 (1.2) | −1.52 | <0.0001 | 4.9 (1.1) | 3.9 (1.2) | −1.1 (1.2) | −0.87 | <0.0001 | −0.54 | <0.0001 | −0.42 | <0.0001 |
| ADHD symptoms by K-SADS-E | ||||||||||||||
| Inattention | 8.5 (0.8) | 4.9 (3.0) | −3.6 (3.1) | −1.64 | <0.0001 | 8.5 (0.8) | 6.3 (2.8) | −2.2 (2.8) | −1.07 | <0.0001 | −0.48 | 0.000 | −0.47 | 0.000 |
| Hyperactivity/impulsiveness | 6.3 (2.7) | 3.1 (2.9) | −3.2 (3.3) | −1.14 | <0.0001 | 6.4 (2.8) | 4.3 (2.9) | −2.1 (2.8) | −0.74 | <0.0001 | −0.41 | 0.000 | −0.36 | 0.000 |
ITT, intent to treat; ADHD, attention-deficit/hyperactivity disorder; SNAP-IV, The Chinese version of the Swanson, Nolan, and Pelham, version IV; CTRS-R: S, The Chinese version of the Conner's Teacher Rating Scales Revised: Short; CGI-ADHD-S, The Clinical Global Impression-ADHD severity; K-SADS-E, The Chinese version of the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological; SD, standard deviation; MPH, methylphenidate.