Table 4.
Side Effect Ratings
| PSERS | Baseline Mean (SD) | End-point Mean (SD) | p value |
|---|---|---|---|
| PSERS Total Score | 7.5 (4.2) | 6.9 (4.2) | 0.45 |
| PSERS Mood Score | 4.8 (2.7) | 4 (3) | 0.15 |
| Motor tics | 0.05 (0.2) | 0.2 (0.5) | 0.06 |
| Buccal-lingual movements | 0.08 (0.4) | 0.2 (0.5) | 0.25 |
| Picking at skin or fingers, nail biting, lip or cheek chewing | 0.95 (0.84) | 0.82 (0.93) | 0.34 |
| Worried/anxious | 0.95 (0.84) | 0.82 (0.87) | 0.40 |
| Dull, tired, listless | 0.5 (0.7) | 0.4 (0.6) | 0.59 |
| Headaches | 0.3 (0.6) | 0.4 (0.7) | 0.62 |
| Stomachache | 0.4 (0.7) | 0.5 (0.7) | 0.30 |
| Crabby, irritable | 1.4 (0.9) | 1.1 (0.8) | 0.04* |
| Tearful, sad, depressed | 0.7 (0.8) | 0.5 (0.7) | 0.24 |
| Socially withdrawn | 0.5 (0.7) | 0.4 (0.7) | 0.60 |
| Hallucinations | 0.1 (0.4) | 0.08 (0.4) | 0.57 |
| Loss of appetite | 0.9 (1.1) | 0.9 (0.7) | 1 |
| Trouble sleeping | 0.7 (0.9) | 0.7 (0.7) | 0.87 |
*
p value: <0.05.
SD, standard deviation; PSERS Total Score, Pittsburgh Side Effect Rating Scale – Total Score (range 0–39); PSERS Mood Score, Pittsburgh Side Effect Rating Scale – Mood Score (range (0–18; addition of the following six PSERS items “Worried/anxious,” “Dull, tired, listless,” “Crabby, irritable,” “Tearful, sad, depressed,” “Socially withdrawn,” and “Trouble sleeping”); PSERS Item: 0=None, 1=Mild, 2=Moderate, 3=Severe.