Table 3.
Change in primary and secondary efficacy measures from screening to week 12
| Median score | Mean (SD) score | Median change from screening to week 12 | |||||
|---|---|---|---|---|---|---|---|
| Screening (n = 18) | Week 12 (n = 18) | Screening (n = 18) | Week 12 (n = 18) | Score (% change) | Paired-samples t test | ||
| t | Cohen’s d | ||||||
| Primary efficacy measures | |||||||
| ADAMS | |||||||
| Total | 32.00 | 18.00 | 32.10 (14.36) | 18.10 (8.32) | − 15.50 (− 48.90%) | − 5.74*** | 1.36 |
| Manic/hyperactive | 9.00 | 6.00 | 8.80 (3.99) | 6.10 (3.29) | − 2.50 (− 32.50%) | − 4.51*** | 1.05 |
| Depressed mood | 2.00 | 1.00 | 2.90 (3.94) | 2.00 (2.35) | 0.00 | − 1.54 | 0.37 |
| Social avoidance | 10.00 | 5.00 | 9.90 (5.18) | 4.80 (2.07) | − 5.50 (− 55.40%) | − 4.79*** | 1.14 |
| General anxiety | 10.00 | 4.50 | 9.40 (4.35) | 4.60 (3.35) | − 5.00 (− 52.30%) | − 7.19*** | 1.70 |
| Compulsive behavior | 2.50 | 1.50 | 2.70 (2.40) | 1.40 (1.42) | − 2.00 (− 57.10%) | − 2.43* | 0.56 |
| Secondary efficacy measures | |||||||
| ABC-CFXS | |||||||
| Social avoidance | 4.50 | 2.50 | 5.10 (3.46) | 2.30 (2.22) | − 3.00 (− 66.70%) | − 4.31*** | 1.00 |
| Stereotypy | 8.50 | 2.00 | 8.10 (5.91) | 3.20 (3.07) | − 5.00 (− 69.00%) | − 4.20*** | 0.99 |
| Socially unresponsive/lethargic | 8.00 | 4.00 | 9.20 (6.40) | 4.10 (4.09) | − 5.00 (− 65.20%) | − 3.40** | 0.76 |
| Irritability | 18.50 | 8.50 | 17.70 (12.68) | 10.60 (11.03) | − 7.50 (− 50.00%) | − 2.92** | 0.69 |
| Hyperactivity | 10.50 | 8.50 | 13.70 (9.09) | 9.80 (7.38) | − 3.50 (− 29.80%) | − 2.49* | 0.59 |
| Inappropriate speech | 6.00 | 3.50 | 5.90 (2.30) | 3.50 (2.66) | − 3.00 (− 44.40%) | − 3.69** | 0.87 |
| PARS-R | |||||||
| Total severity (5-item) | 14.50 | 9.50 | 15.70 (3.88) | 10.60 (3.43) | − 6.00 (− 38.20%) | − 4.18*** | 0.98 |
| PedsQL | |||||||
| Total score | 65.20 | 67.80 | 57.80 (18.78) | 67.70 (18.27) | 9.80 (16.70%) | 2.98* | 0.77 |
| Physical functioning | 68.80 | 79.70 | 67.90 (27.36) | 78.00 (22.39) | 6.30 (7.10%) | 2.04 | 0.53 |
| Emotional functioning | 60.00 | 80.00 | 64.00 (20.72) | 78.30 (16.63) | 10.00 (11.10%) | 2.27* | 0.58 |
| Social functioning | 40.00 | 50.00 | 37.30 (24.70) | 49.00 (24.35) | 10.00 (27.80%) | 1.95 | 0.50 |
| School functioning | 55.00 | 55.00 | 55.70 (19.17) | 59.10 (22.47) | 0.00 | 0.95 | 0.25 |
| Psychosocial health | 51.70 | 62.90 | 52.40 (17.22) | 62.20 (18.91) | 8.30 (16.10%) | 2.25* | 0.58 |
| VAS | |||||||
| Hyperactivity/impulsivity | 6.70 | 3.50 | 5.90 (2.43) | 3.60 (2.49) | − 1.70 (− 44.60%) | − 4.77*** | 1.10 |
| Tantrum/mood lability | 5.40 | 2.90 | 4.70 (2.09) | 3.20 (2.18) | − 1.00 (− 33.90%) | − 3.59** | 0.86 |
| Anxiety | 6.50 | 3.80 | 6.00 (2.05) | 3.80 (1.93) | − 2.20 (− 35.40%) | − 4.25*** | 1.01 |
| CGI | |||||||
| CGI-S | 5.00 | – | 5.10 (1.39) | – | – | – | – |
| CGI-I | – | 2.00 | – | 2.50 (1.01) | – | – | – |
Note. Prior to tabulation change in score at week 12 was calculated for each subject by (change = score at week 12 − score at screening), and percent change in score at week 12 was calculated for each subject by [% Change = 100 × (change at week 12/score at screening)]
*p<.05 compared to screening
**p<.01 compared to screening
***p<.001 compared to screening