Table 5.
Comparison of Subjects After Two Years of Treatment as a Function of Risperidone Exposure (Number of Days) and Recent Treatment
| Non-risperidone group | Risperidone group | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Follow-up | Baseline | Follow-up | |||||
| Variable name | p total exposure | n | Mean (SD) | Mean (SD) | n | Mean (SD) | Mean (SD) | p last 4 weeks (1) |
| AIMS | ||||||||
| 1. Q1 to Q7 Total | NA | 25 | 0.52 (1.29) | 0.32 (0.99) | 57 | 0.26 (1.01) | 0.07 (0.26) | NA |
| 2. Q8 (Severity) | NA | 25 | 0.16 (0.47) | 0.0 (0.0) | 57 | 0.04 (0.26) | 0.05 (0.23) | NA |
| Simpson–Angus Scale | ||||||||
| 1. Simpson Total | 0.6763 | 25 | 2.28 (4.72) | 1.20 (3.03) | 57 | 1.91 (5.81) | 0.49 (1.69) | 0.1862 |
| Weight and height | ||||||||
| 1. Weight score z | 0.3759 | 24 | 0.19 (1.74) | 0.47 (1.63) | 48 | 0.64 (1.25) | 1.18 (1.06) | 0.0304+ |
| 2. Body mass index z | 0.8705 | 24 | 0.38 (1.60) | 0.85 (1.28) | 44 | 0.56 (1.33) | 1.06 (1.13) | 0.6206 |
| 3. Height z | 0.0112+ | 24 | −0.12 (1.62) | −0.38 (1.69) | 45 | 0.26 (1.15) | 0.60 (1.25) | 0.0052+ |
| CY-BOCS | ||||||||
| 1. Total Score (0–20)‡ | 0.9810 | 25 | 16.00 (3.29) | 13.08 (4.60) | 55 | 15.29 (3.15) | 11.67 (4.48) | 0.3000 |
| Intelligence quotient | ||||||||
| 1. IQ | 0.9699 | 20 | 46.74 (30.57) | 45.85 (32.22) | 39 | 50.52 (23.07) | 48.73 (23.92) | 0.7586 |
| Vineland Adaptive Behavior Scales | ||||||||
| 1. Communication | 0.921 | 24 | 44.21 (17.43) | 45.21 (21.09) | 52 | 42.81 (14.75) | 43.19 (18.45) | 0.8296 |
| 2. Daily Living Skills | 0.2215 | 24 | 33.25 (15.20) | 38.54 (21.60) | 52 | 38.56 (18.44) | 40.56 (20.30) | 0.5804 |
| 3. Social Skills | 0.0516+ | 24 | 48.83 (18.19) | 44.21 (18.07) | 52 | 47.40 (11.71) | 50.63 (15.10) | 0.0110+ |
| 4. Motor Skills | 0.0826− | 16 | 56.88 (24.63) | 63.06 (27.17) | 32 | 60.34 (19.86) | 61.94 (15.72) | 0.5432 |
| 5. Adaptive Behavior C. | 0.8091 | 24 | 38.58 (15.38) | 38.96 (18.02) | 51 | 41.55 (15.63) | 40.25 (15.51) | 0.7090 |
| Clinical Global Impressions (CGI) | ||||||||
| 1. CGI Severity† | 0.6799 | 26 | 5.23 (0.65) | 4.65 (1.09) | 55 | 5.09 (0.7) | 4.40 (0.89) | 0.3004 |
| Aberrant Behavior Checklist | ||||||||
| 1. Irritability | 0.9738 | 27 | 23.44 (7.24) | 17.78 (10.82) | 55 | 27.22 (7.28) | 14.82 (8.40) | 0.0147− |
| 2. Social Withdrawal | 0.4005 | 27 | 18.52 (9.72) | 13.33 (8.73) | 56 | 16.05 (8.55) | 8.43 (6.77) | 0.0130− |
| 3. Stereotypic Behavior | 0.8034 | 25 | 8.84 (5.22) | 6.76 (5.37) | 56 | 10.50 (4.43) | 6.02 (4.40) | 0.0866− |
| 4. Hyperactivity/Noncompliance | 0.2152 | 24 | 28.58 (10.40) | 23.38 (12.06) | 53 | 34.30 (7.95) | 17.68 (10.16) | 0.0020− |
| 5. Inappropriate Speech | 0.9494 | 27 | 5.59 (4.03) | 5.15 (4.24) | 56 | 5.71 (3.93) | 3.86 (3.01) | 0.0433− |
| M-RLRS | ||||||||
| 1. Sensory Motor | 0.4966 | 25 | 4.76 (2.98) | 4.20 (3.42) | 55 | 6.95 (4.28) | 4.67 (3.06) | 0.3721 |
| 2. Social Relationships | 0.6485 | 25 | 6.28 (4.32) | 2.40 (3.16) | 55 | 6.55 (4.29) | 1.02 (4.23) | 0.0723− |
| 3. Affectual Responses | 0.3049 | 25 | 5.20 (1.94) | 4.04 (1.88) | 55 | 6.13 (1.90) | 3.49 (1.88) | 0.0455− |
| 4. Sensory Responses | 0.0920− | 25 | 19.24 (8.80) | 14.80 (7.08) | 55 | 20.96 (9.06) | 11.02 (7.10) | 0.0007− |
| 5. Language | 0.8099 | 25 | 4.92 (4.65) | 1.96 (4.30) | 55 | 2.67 (4.31) | −0.15 (3.99) | 0.3123 |
Non-risperidone group comprises subjects not taking risperidone in last 4 weeks before follow-up; risperidone group comprises subjects receiving risperidone prior to follow-up.
All analyses were by ANCOVA, except for the CGI-S, tagged with †, where logistic regression was used and p values for Wald tests are reported. This ordinal variable was converted into a binary variable based on whether improvement was observed or not during the follow-up period relative to the baseline. In both analyses, baseline value was used as a covariate (always significant) and only one of the predictor variables was used. The signs that accompany the p values <0.10 correspond to the direction of association between the response and the corresponding predictor. The mean percent of risperidone exposure for the 28 patients who had not been taking risperidone in the past 4 weeks was 18.98%, and for the 56 patients who were taking risperidone in the past week it was 88.86%.
NA, complete separation of data points observed in logistic regression.
For CY-BOCS total score, lag follow-up was also included as a covariate in the ANCOVA models. Lag had no effect on all remaining variables.
The sign (+/−) affixed to total exposure indicates the direction of the relationship.
AIMS, Abnormal Involuntary Movement Scale; CY-BOCS, Children's Yale-Brown Obsessive Compulsive Scale; M-RLRS, Modified Real Life Rating Scale for Autism.