Table 5.
Side effects reported at baseline and during study period. Values are numbers (percentages) of patients (n=178)
| Side effects | Baseline | Study period | |||||
|---|---|---|---|---|---|---|---|
| Quetiapine group (n=89) | Placebo group (n=89) | P value* | Quetiapine group (n=89) | Placebo group (n=89) | P value* | ||
| UKU36†: | |||||||
| Concentration difficulties | 9 (10) | 23 (26) | 0.01 | 37 (42) | 47 (53) | 0.18 | |
| Asthenia, lassitude, or increased fatigability | 19 (21) | 24 (27) | 0.48 | 52 (58) | 46 (52) | 0.45 | |
| Sleepiness or sedation | 23 (26) | 19 (21) | 0.60 | 62 (70) | 44 (49) | 0.01 | |
| Failing memory | 7 (8) | 14 (16) | 0.16 | 33 (37) | 30 (34) | 0.75 | |
| Depression | 1 (1) | 1 (1) | >0.99 | 16 (18) | 12 (13) | 0.54 | |
| Tension or inner unrest | 2 (2) | 1 (1) | >0.99 | 19 (21) | 14 (16) | 0.44 | |
| Increased duration of sleep | 10 (11) | 13 (15) | 0.66 | 45 (51) | 35 (39) | 0.18 | |
| Reduced duration of sleep | 1 (1) | 1 (1) | >0.99 | 22 (25) | 30 (34) | 0.25 | |
| Tremor | 4 (4) | 4 (4) | >0.99 | 16 (18) | 13 (15) | 0.69 | |
| Reduced salivation | 1 (1) | 0 | >0.99 | 13 (15) | 4 (4) | 0.04 | |
| Constipation | 2 (2) | 0 | 0.50 | 13 (15) | 4 (4) | 0.04 | |
| Weight gain | 22 (25) | 19 (21) | 0.72 | 35 (39) | 30 (34) | 0.54 | |
| Weight loss | 0 | 1 (1) | >0.99 | 9 (10) | 23 (26) | 0.01 | |
| Amenorrhoea | 6/50 (12) | 5/48 (10) | 0.77 | 12/50 (24) | 11/48 (23) | >0.99 | |
| Headache | 4 (4) | 2 (2) | 0.68 | 19 (21) | 16 (18) | 0.71 | |
| Akathisia (BARS37)‡ | 0 | 0 | >0.99 | 1 (1) | 0 | >0.99 | |
| Dyskinesia (AIMS38)§ | 0 | 0 | >0.99 | 0 | 1 (1) | 0.48 | |
| Parkinsonism (SAS39)¶ | 0 | 0 | >0.99 | 0 | 1 (1) | >0.99 | |
AIMS=abnormal involuntary movement scale; BARS=Barnes akathisia rating scale; SAS=Simpson Angus scale; UKU=Udvalg for Kliniske Undersøgelser scale.
*Based on χ2 comparisons between quetiapine and placebo groups, or Fisher’s exact test when number of side effects in group is <5.
†Side effects scored as 1 (mild) or higher at baseline or at any time during the study period; extrapyramidal side effects were as defined in CATIE study,44 with thresholds adjusted for first episode patients.
‡BARS global clinical assessment score ≥2, indicating akathisia of mild or greater severity.
§AIMS global severity score ≥2, indicating abnormal involuntary movements of mild or greater severity.
¶SAS mean score ≥1, indicating extrapyramidal signs of moderate severity.