Table 1.
Baseline characteristics of randomised participants. Values are numbers (percentages) unless stated otherwise
| Characteristics | Allocated groups | ||
|---|---|---|---|
| Mirtazapine+SSRI or SNRI (n=241) | Placebo+SSRI or SNRI (n=239) | ||
| Stratification variable | |||
| Site: | |||
| Bristol | 89 (37) | 88 (37) | |
| Exeter | 61 (25) | 61 (25) | |
| Keele/North Staffs | 41 (17) | 41 (17) | |
| Hull | 50 (21) | 49 (21) | |
| Minimisation variables | |||
| Women | 168 (70) | 164 (69) | |
| Baseline BDI II score: | |||
| 14-25 | 77 (32) | 79 (33) | |
| 26-34 | 78 (32) | 78 (33) | |
| ≥35 | 86 (36) | 82 (34) | |
| Currently receiving psychological services | 33 (14) | 29 (12) | |
| Sociodemographic variables | |||
| Mean (SD) age (years) | 50.4 (13.8) | 49.9 (12.5) | |
| Ethnic group: | |||
| White | 233 (97) | 235 (98) | |
| Non-white | 8 (2) | 4 (2) | |
| Marital status: | |||
| Married or cohabiting | 142 (59) | 135 (56) | |
| Single | 47 (20) | 53 (22) | |
| Separated, divorced, or widowed | 52 (22) | 51 (21) | |
| Employment status: | |||
| Not working | 132 (55) | 104 (44) | |
| Educational attainment: | |||
| A level or higher | 115 (48) | 115 (48) | |
| GSCE, standard grade, or O level or equivalent | 72 (30) | 78 (33) | |
| No formal qualification | 54 (22) | 46 (19) | |
| Financial wellbeing: | |||
| Just about getting by or worse | 130 (54) | 126 (53) | |
| Median (interquartile range) alcohol use score* | 2.0 (1.0-4.0) | 2.0 (1.0-4.0) | |
| Mean (SD) No of life events in past six months | 1.0 (1.0) | 1.1 (1.0) | |
| Mean (SD) social support score | 12.2 (4.1) | 12.8 (4.0) | |
| Caring responsibilities | |||
| Providing care for someone with a disability | 30 (12) | 37 (15) | |
| Measures of depression | |||
| Previous depression | 206 (85) | 190 (79) | |
| Previous referral to psychiatrist for depression†: | 71 (34) | 60 (32) | |
| Previous episodes of depression‡: | |||
| 0 | 3 (1) | 5 (3) | |
| 1 | 14 (7) | 8 (4) | |
| 2-4 | 82 (40) | 79 (42) | |
| ≥5 | 107 (52) | 98 (52) | |
| Length of current course of antidepressants (months): | |||
| <6 | 26 (11) | 20 (8) | |
| ≥6 | 215 (89) | 219 (92) | |
| ICD-10 primary diagnosis: | |||
| Mild | 38 (16) | 44 (18) | |
| Moderate | 138 (57) | 144 (60) | |
| Severe | 65 (27) | 51 (21) | |
| Mean (SD) scores: | |||
| CIS-R | 28.3 (8.2) | 27.0 (8.3) | |
| BDI II | 31.5 (10.2) | 30.6 (9.6) | |
| GAD-7§ | 11.3 (4.8) | 10.7 (4.8) | |
| PHQ-9 | 16.7 (5.5) | 16.0 (5.5) | |
| EQ-5D-5L¶ | 0.65 (0.26) | 0.69 (0.22) | |
| SF-12 aggregate physical functioning** | 45.7 (13.8) | 46.4 (13.1) | |
| SF-12 aggregate mental functioning** | 27.9 (9.6) | 29.2 (9.7) | |
| Suicidal ideation: | |||
| None | 81 (34) | 119 (50) | |
| Patient feels life isn’t worth living | 59 (24) | 44 (18) | |
| Suicidal thoughts/plans | 101 (42) | 76 (32) | |
SSRI=selective serotonin reuptake inhibitor; SNRI=serotonin-noradrenaline reuptake inhibitor; BDI II=Beck depression inventory, second revision; ICD-10=international classification of diseases, 10th revision; CIS-R=revised clinical interview schedule; GAD=generalised anxiety disorder; PHQ=patient health questionnaire.
*
AUDIT score.26
Number of missing observations by treatment group: †n=35 mirtazapine, n=49 placebo; ‡n=35 mirtazapine, n=49 placebo; §n=3 mirtazapine, n=0 placebo; ¶n=1 mirtazapine, n=1 placebo; **n=7 mirtazapine, n=4 placebo.