Table 2.
Comparisons of participant primary outcomes at 12 weeks and 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) | ||||
| 12-week primary outcome | |||||||
| Agitation: CMAI | 79 | 61·4 (22·6) | 87 | 60·8 (21·8) | 0·59 (−6·22 to 7·40) | −1·74 (−7·17 to 3·69)*; −0·93 (−6·42 to 4·56)† | 0·530; 0·739 |
| 6-week secondary outcomes | |||||||
| Agitation: CMAI | 84 | 61·4 (23·5) | 88 | 60·0 (19·9) | 1·39 (−5·15 to 7·93) | −0·55 (−6·18 to 5·08) | 0·848 |
| Cognition: standardised MMSE | 33 | 15·5 (7·1) | 31 | 16·2 (7·2) | −0·68 (−4·25 to 2·89) | −0·14 (−1·17 to 1·45) | 0·836 |
| Quality of life: DEMQOL | 32 | 95·1 (10·2) | 32 | 96·8 (8·4) | −1·69 (−6·38 to 3·00) | 1·12 (−2·74 to 4·97) | 0·570 |
| Quality of life: DEMQOL-proxy | 79 | 96·6 (14·7) | 86 | 94·6 (16·2) | 2·03 (−2·74 to 6·79) | 0·80 (−3·18 to 4·77) | 0·694 |
| Quality of life: EQ-5D, proxy report by carer | 82 | 0·48 (0·33) | 87 | 0·56 (0·30) | −0·08 (−0·17 to 0·02) | −0·07 (−0·13 to 0·00) | 0·061 |
| Neuropsychiatric symptoms: NPI total score | 84 | 27·1 (20·0) | 88 | 24·8 (20·0) | 2·29 (−3·73 to 8·31) | 2·03 (−2·89 to 6·95) | 0·419 |
| Neuropsychiatric symptoms: NPI agitation and aggression subscore | 84 | 4·0 (3·6) | 88 | 4·2 (3·5) | −0·20 (−1·28 to 0·87) | −0·34 (−1·30 to 0·62) | 0·490 |
| Neuropsychiatric symptoms: NPI depression, anxiety, and irritability subscore | 84 | 7·9 (7·7) | 88 | 7·2 (8·2) | 0·68 (−1·72 to 3·07) | 0·70 (−1·24 to 2·63) | 0·482 |
| 12-week secondary outcomes | |||||||
| Cognition: standardised MMSE | 23 | 18·0 (6·0) | 27 | 15·6 (7·5) | 2·44 (−1·48 to 6·37) | 1·45 (−0·20 to 3·10) | 0·084 |
| Quality of life: DEMQOL | 24 | 94·3 (7·1) | 24 | 97·1 (8·4) | −2·83 (−7·35 to 1·68) | −1·36 (−5·82 to 3·10) | 0·549 |
| Quality of life: DEMQOL-proxy | 71 | 98·4 (14·5) | 82 | 97·5 (12·4) | 0·93 (−3·37 to 5·23) | 0·44 (−3·09 to 3·96) | 0·809 |
| Quality of life: EQ-5D, proxy report by carer | 77 | 0·46 (0·35) | 84 | 0·50 (0·33) | −0·04 (−0·14 to 0·07) | −0·01 (−0·08 to 0·07) | 0·822 |
| Neuropsychiatric symptoms: NPI total score | 75 | 23·9 (17·8) | 84 | 25·7 (19·6) | −1·80 (−7·69 to 4·09) | −2·02 (−6·67 to 2·62) | 0·393 |
| Neuropsychiatric symptoms: NPI agitation and aggression subscore | 76 | 4·1 (3·4) | 84 | 4·5 (3·6) | −0·40 (−1·49 to 0·70) | −0·52 (−1·52 to 0·47) | 0·305 |
| Neuropsychiatric symptoms: NPI depression, anxiety, and irritability subscore | 75 | 6·9 (6·7) | 84 | 7·3 (8·0) | −0·44 (−2·77 to 1·88) | −0·58 (−2·43 to 1·27) | 0·541 |
CMAI=Cohen Mansfield Agitation Inventory. DEMQOL=disease-specific health-related quality of life. EQ-5D=EuroQOL 5 dimension. MMSE=mini-mental state examination. NPI=neuropsychiatric inventory.
*
Adjusted for prespecified factors: baseline CMAI, household status, and centre.
†
Adjusted for sex and prespecified factors: baseline CMAI, household status, and centre.