Table 3.
Summary of Clinical Global Impression-Improvement Ratings at Beginning and End of the Double-Blind Phase 5
| Number (%) with the rating | ITT-E |
DBC-15 |
||
|---|---|---|---|---|
| MPH-MLR (n = 39) | Placebo (n = 50) | MPH-MLR (n = 28) | Placebo (n = 26) | |
| CGI-I (Visit 15) | ||||
| 1 = Very much improved | 6 (15.4) | 5 (10.0) | 5 (17.9) | 3 (11.5) |
| 2 = Much improved | 8 (20.5) | 6 (12.0) | 8 (28.6) | 6 (23.1) |
| 3 = Minimally improved | 3 (7.7) | 4 (8.0) | 3 (10.7) | 2 (7.7) |
| 4 = No change | 11 (28.2) | 13 (26.0) | 10 (35.7) | 10 (38.5) |
| 5 = Minimally worse | 4 (10.3) | 1 (2.0) | 2 (7.1) | 1 (3.8) |
| 6 = Much worse | 6 (15.4) | 16 (32.0) | 0 | 4 (15.4) |
| 7 = Very much worse | 1 (2.6) | 5 (10.0) | 0 | 0 |
| Between-group Cochran–Mantel–Haenszel statistic: row mean scores difference p-valuea | 0.045a | 0.128b | ||
Cochran–Mantel–Haenszel p-value for the comparison of the MPH-MLR treatment group to the placebo group distribution of CGI-S ratings across the seven possible responses at the given time point.
Cochran–Mantel–Haenszel p-value for the comparison of the MPH-MLR treatment group to the placebo group distribution of CGI-I ratings across the 7 possible responses at the given time point.
CGI-I, Clinical Global Impression—Improvement scale; DBC-15, children in the double-blind compliant population who had 15 ± 3 days of participation in the double-blind phase of the study; ITT-E, intention-to-treat—efficacy evaluable; MPH-MLR, methylphenidate hydrochloride extended-release capsules.