Table 3.
Change in outcome measures with treatment
| Estimate (95%CL) | Estimate (95%CL) p value |
Effect sized pooled sd | |||
|---|---|---|---|---|---|
| Baseline | Week 8 | Week 16 | Week 16–baseline | ||
| n | 27 | 25 | 25 | ||
| Social function | |||||
| ABC social withdrawal | 10.1 (6.6; 13.7) | 7.5 (4.8; 10.3) | 6.7 (3.8; 9.6) | − 3.4 (− 5.3; 1.6) 0.0005* | − 0.43 7.96 |
| SRS totala | 88.4 (73.6; 103.2) | 88.2 (78.9; 97.5) | 85.8 (75.2; 96.4) | − 2.6 (− 17.2; 12.0) 0.7 | − 0.09 29.29 |
| Externalizing behaviors | |||||
| ABC irritability | 13.8 (10.2; 17.4) | 11.2 (8.3; 14.0) | 10.0 (6.9; 13.0) | − 3.8 (− 6.3; − 1.3) 0.004* | − 0.46 8.27 |
| ABC hyperactivity | 21.7 (17.6; 25.7) | 18.7 (14.9; 22.4) | 16.5 (13.2; 19.7) | − 5.2 (− 7.8; − 2.6) 0.0003* | − 0.58 8.96 |
| Anxiety | |||||
| BASC-2 anxietyb | 8.9 (5.5; 12.2) | 8.1 (5.3; 10.8) | 8.2 (5.2; 11.3) | − 0.6 (− 2.8; 1.5) 0.6 | − 0.08 7.76 |
| CASI-4 generalized anxietyc | 6.6 (5.1; 8.0) | 5.4 (4.3; 6.6) | 5.2 (4.0; 6.3) | − 1.4 (− 2.5; − 0.3) 0.02 | − 0.44 3.16 |
| CASI-4 social phobiac | 2.4 (1.6; 3.3) | 2.2 (1.4; 3.0) | 1.6 (1.1; 2.1) | − 0.8 (− 1.5; − 0.2) 0.01 | − 0.50 1.66 |
| CASI-4 separation anxietyc | 2.4 (1.3; 3.5) | 1.8 (1.1; 2.6) | 1.6 (0.8; 2.4) | − 0.8 (− 1.6; 0.1) 0.08 | − 0.33 2.32 |
| Repetitive behaviors | |||||
| RBSR total | 33.0 (25.7; 40.3) | 27.5 (20.6; 34.3) | 24.5 (17.4; 31.5) | − 8.5 (− 13.3; − 3.7) 0.0009* | − 0.48 17.62 |
| CY-BOCSa | 12.6 (11.1; 14.2) | 10.7 (9.4; 12.1) | 9.4 (8.0; 10.9) | − 3.2 (− 4.4; − 2.0) < .0001* | − 0.90 3.54 |
| Clinical global impression | % Responders: score of 1 or 2 (95%CL) | ||||
| Week 8 | Week 16 | ||||
| n | 25 | 27 | |||
| CGI social | 20.3 (9.4; 38.2) |
34.1 (18.6; 54.0) |
|||
| CGI global | 26.0 (11.7; 48.1) |
45.8 (27.8; 65.0) |
|||
Score (95%CL) at each visit is estimated from a repeated measures linear model controlling for age; a planned contrast is used to estimate the change from baseline to week 16 from the model; model excludes one participant with a placebo response at week 2
an = 26 at baseline and week 16
bn = 24 at week 8
cn = 26 at week 16; * = remains significant using Bonferroni adjusted level for significance of p = 0.005
dWeek 16–baseline/pooled standard deviation where the pooled standard deviation is derived from the baseline and week 16 standard deviations obtained from the repeated measures model