Table 2.
Common treatment-emergent adverse events (most to least prevalent)
| Adverse event | Quetiapine XR n = 13 (N, %) | Placebo n = 13 (N, %) |
|---|---|---|
| Somnolencea | 10 (77 %) | 5 (38 %) |
| Anxiety | 4 (31 %) | 0 (0 %) |
| Constipation | 3 (23 %) | 1 (8 %) |
| Dry mouth | 3 (23 %) | 0 (0 %) |
| Dizziness | 2 (15 %) | 3 (23 %) |
| Restlessness | 2 (15 %) | 4 (31 %) |
| Derealizationa | 2 (15 %) | 0 (0 %) |
| Insomnia | 1 (8 %) | 3 (23 %) |
| Increased appetite | 1 (8 %) | 2 (15 %) |
| Leg pain | 1 (8 %) | 1 (8 %) |
| Weight loss | 1 (8 %) | 0 (0 %) |
| Shakiness | 1 (8 %) | 0 (0 %) |
| Muscle aches | 0 (0 %) | 2 (15 %) |
| Weight gain | 0 (0 %) | 1 (8 %) |
No significant differences between groups were detected at the p < 0.05 level (Fisher’s exact test)
a3 patients in the XR group discontinued due to side-effects (somnolence or derealization). There were no serious AEs (ones requiring ER or inpatient care)