Table 3.
Comparisons of carer secondary outcomes at 6 weeks and 12 weeks
|
Mirtazapine group (n=102) |
Placebo group (n=102) |
Mean difference (95% CI) | Adjusted mean difference*(95% CI) | p value | |||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | ||||
| 6-week outcomes | |||||||
| Carer GHQ-12 | 50 | 12·8 (6·2) | 54 | 12·1 (4·9) | 0·69 (−1·46 to 2·85) | 0·61 (−1·21 to 2·42) | 0·512 |
| Carer EQ-5D | 50 | 0·83 (0·16) | 55 | 0·83 (0·15) | 0·00 (−0·06 to 0·06) | 0·01 (−0·04 to 0·05) | 0·821 |
| Zarit Carer Burden Inventory | 46 | 34·7 (16·3) | 49 | 29·4 (13·9) | 5·35 (0·82 to 11·53) | 3·76 (−0·30 to 7·83) | 0·069 |
| NPI carer distress subscore | 78 | 11·5 (1·1) | 84 | 10·2 (8·8) | 1·37 (−1·45 to 4·19) | 1·48 (−0·78 to 3·73) | 0·199 |
| 12-week outcomes | |||||||
| Carer GHQ-12 | 44 | 13·1 (6·0) | 52 | 12·2 (5·4) | 0·88 (−1·43 to 3·19) | 0·36 (−1·58 to 2·31) | 0·714 |
| Carer EQ-5D | 46 | 0·80 (0·16) | 49 | 0·82 (0·19) | −0·02 (−0·09 to 0·06) | 0·02 (−0·04 to 0·07) | 0·561 |
| Zarit Carer Burden Inventory† | 42 | 35·5 (17·2) | 48 | 29·0 (15·8) | 6·48 (−0·43 to 13·39) | 5·01 (0·80 to 9·23) | 0·020 |
| NPI carer distress subscore | 72 | 10·0 (8·6) | 81 | 10·5 (8·3) | −0·52 (−3·22 to 2·17) | −0·27 (−2·34 to 1·80) | 0·798 |
CMAI=Cohen-Mansfield Agitation Inventory. GHQ-12=12-item General Health Questionnaire. NPI=neuropsychiatric inventory.
*
Adjusted for prespecified factors: baseline CMAI, household status, and centre.
†
Asked of family carers only.