Table 1.
Comparisons between subjects with follow-up and subjects without follow-up.
| N=124 | No Follow-up n=37 (30%) | With Follow-up n=87 (70%) | p –value |
|---|---|---|---|
|
| |||
| Male | 33 (89%) | 72 (83%) | 0.43 |
|
| |||
| Combination treatment group | 24 (65%) | 51 (59%) | 0.45 |
|
| |||
| White | 25 (68%) | 68 (78%) | 0.26 |
|
| |||
| Site: IU/OSU/YALE | 17/12/8 (46%/32%/22%) | 24/37/26 (28%/42%/30%) | 0.14 |
|
| |||
| Diagnosis: Autistic Disorder/Asperger’s Disorder/PDD-NOS | 22/0/15 (59%/0%/41%) | 59/8/20 (68%/9%/23%) | 0.04 |
|
| |||
| Age | |||
| Mean (SD) | 7.17 (2.72) | 7.54 (2.33) | 0.45 |
| Median (range) | 6.35 (4.01–13.80) | 7.30 (4.07–13.46) | |
|
| |||
| Taking RIS at the end of RUPP main study: | |||
| First row: taking at week 24 | 14 (38%) | 66 (76%) | <0.0001 |
| 2nd row: taking at LOCF | 21 (57%) | 74 (85%) | 0.001 |
|
| |||
| Dose of RIS: Mean daily mg (sd) (range) at 24 weeks | 2.00 (0.50–3.25) | 2.13 (0.75–3.50) | 0.30 |
|
| |||
| HSQ Mean(SD) at Baseline: | 3.94 (1.60) | 4.38 (1.57) | 0.87 |
|
| |||
| HSQ Mean(SD) at Main Study End (24 weeks) | 1.50 (1.61) | 1.51 (1.31) | 0.97 |
|
| |||
| HSQ Yes at Baseline, out of 25 possible yeses | 17.24 (4.49) | 19.32 (3.94) | 0.011 |
|
| |||
| HSQ Yes at EOS, out of 25 possible yeses | 9.89 (6.5) | 11.07 (6.9) | 0.38 |
|
| |||
| ABC Irritability Subscale at baseline | 29.7 (7.4) | 29.38 (6.30) | 0.81 |
|
| |||
| ABC Irritability Subscale at main study end | 12.84 (9.18) | 12.95 (7.96) | 0.94 |
|
| |||
| ABC Lethargy Subscale at baseline | 15.65 (8.23) | 16.07 (9.05) | 0.8085 |
|
| |||
| ABC Lethargy Subscale at Main Study End | 5.51 (6.79) | 5.30 (6.05) | 0.862 |
|
| |||
| ABC Stereotypy Subscale at baseline | 8.62 (5.70) | 8.82 (5.41) | 0.8573 |
|
| |||
| ABC Stereotypy Subscale at Main Study End | 4.78 (5.13) | 4.40 (4.89) | 0.6958 |
|
| |||
| ABC Hyperactivity Subscale 4 at baseline | 36.97 (9.02) | 35.07 (8.10) | 0.2495 |
|
| |||
| ABC Hyperactivity Subscale 4 at EOS | 17.92 (12.47) | 18.05 (10.82) | 0.9546 |
|
| |||
| ABC Inappropriate Speech Subscale at baseline | 6.41 (3.72) | 5.82 (3.68) | 0.4164 |
|
| |||
| ABC Inappropriate Speech Subscale at EOS | 3.54 (3.47) | 2.69 (2.99) | 0.142 |
Note: IU = Indiana University; OSU = Ohio State University; PDD-NOS = pervasive developmental disorder not otherwise specified; RIS = Risperidone; RUPP = Research Units on Pediatric psychopharmacology (main study, ending at 24 weeks; LOCF = last observation carried forward from week 16 or later; HSQ = Home Situations Questionnaire, developmental disabilities adaptation; ABC = Aberrant Behavior Checklist; BL = baseline; EOS = end of main study at 24 weeks.