Table 1.
Baseline characteristics
| Sertraline (n=324) | Placebo (n=329) | Overall (n=653) | ||
|---|---|---|---|---|
| Site* | ||||
| Bristol | 131 (40%) | 134 (41%) | 265 (41%) | |
| Liverpool | 58 (18%) | 58 (18%) | 116 (18%) | |
| London | 69 (21%) | 73 (22%) | 142 (22%) | |
| York | 66 (20%) | 64 (19%) | 130 (20%) | |
| CIS-R total score* | ||||
| 0–11 | 67 (21%) | 62 (19%) | 129 (20%) | |
| 12–19 | 84 (26%) | 89 (27%) | 173 (26%) | |
| ≥20–49 | 173 (53%) | 178 (54%) | 351 (54%) | |
| CIS-R depression duration (years)* | ||||
| <2 | 218 (67%) | 221 (67%) | 439 (67%) | |
| ≥2 | 106 (33%) | 108 (33%) | 214 (33%) | |
| Age (years) | ||||
| 18–34 | 132 (41%) | 134 (41%) | 266 (41%) | |
| 35–54 | 125 (39%) | 134 (41%) | 259 (40%) | |
| 55–74 | 67 (21%) | 61 (19%) | 128 (20%) | |
| Sex | ||||
| Female | 203 (63%) | 181 (55%) | 384 (59%) | |
| Male | 121 (37%) | 148 (45%) | 269 (41%) | |
| ICD-10 CIS-R depression diagnosis† | ||||
| Yes | 167 (52%) | 188 (57%) | 355 (54%) | |
| No | 156 (48%) | 141 (43%) | 297 (46%) | |
| ICD-10 CIS-R anxiety diagnosis† | ||||
| Yes | 144 (45%) | 155 (47%) | 299 (46%) | |
| No | 179 (55%) | 174 (53%) | 353 (54%) | |
| Ethnicity† | ||||
| White | 294 (91%) | 285 (87%) | 579 (89%) | |
| Ethnic minority | 29 (9%) | 44 (13%) | 73 (11%) | |
| Marital status† | ||||
| Married or living as married | 116 (36%) | 139 (42%) | 255 (39%) | |
| Single | 152 (47%) | 144 (44%) | 296 (45%) | |
| Separated, divorced, or widowed | 55 (17%) | 46 (14%) | 101 (15%) | |
| Employment status† | ||||
| In paid employment | 209 (65%) | 224 (68%) | 433 (66%) | |
| Not employed | 114 (35%) | 105 (32%) | 219 (34%) | |
| Financial difficulty† | ||||
| Living comfortably or doing alright | 180 (56%) | 184 (56%) | 364 (56%) | |
| Just about getting by | 101 (31%) | 103 (31%) | 204 (31%) | |
| Finding it difficult or very difficult | 42 (13%) | 42 (13%) | 84 (13%) | |
| Highest educational qualification† | ||||
| A Level or higher | 216 (67%) | 234 (71%) | 450 (69%) | |
| GCSE, standard grade, or other | 92 (28%) | 77 (23%) | 169 (26%) | |
| No formal qualification | 15 (5%) | 18 (5%) | 33 (5%) | |
| Depression in the past† | ||||
| Yes | 259 (80%) | 263 (80%) | 522 (80%) | |
| No | 64 (20%) | 66 (20%) | 130 (20%) | |
| Antidepressant in the past† | ||||
| Yes | 191 (59%) | 200 (61%) | 391 (60%) | |
| No | 132 (41%) | 129 (39%) | 261 (40%) | |
| Patient Health Questionnaire, 9-item version total score (possible range 0–27) | 11·79 (5·90) | 12·20 (5·71) | 12·00 (5·80) | |
| CIS-R total score (possible range 0–64) | 20·89 (10·09) | 21·60 (10·19) | 21·25 (10·14) | |
| CIS-R depression severity score (possible range 0–21)‡ | 10·40 (4·95) | 10·76 (4·84) | 10·58 (4·90) | |
| Beck Depression Inventory, second edition total score (possible range 0–63) | 24·01 (10·54) | 23·87 (10·07) | 23·94 (10·30) | |
| Generalised Anxiety Disorder Assessment, 7-item version score (possible range 0–21) | 9·44 (5·39) | 9·42 (5·17) | 9·43 (5·28) | |
| Social support score (possible range 1–24) | 12·46 (4·01) | 12·83 (3·63) | 12·64 (3·82) | |
| SF-12 mental health subscale (possible range 0–100) | 32·96 (10·99) | 31·98 (11·08) | 32·47 (11·04) | |
| SF-12 physical health subscale (possible range 0–100) | 52·19 (9·36) | 51·95 (10·04) | 52·07 (9·70) | |
| Number of life events in past 6 months | 1·20 (1·20) | 1·24 (1·19) | 1·22 (1·19) | |
| Number of physical symptoms in past 2 weeks | 10·01 (4·44) | 10·12 (5·42) | 10·07 (5·42) | |
| Frequency of physical symptoms (possible range 55–112)§ | 43·86 (11·13) | 43·95 (10·80) | 43·91 (10·96) | |
Data are n (%) or mean (SD). One person in the placebo group was missing the PHQ-9 score at baseline and one person in the sertraline group was missing the CIS-R depression score at baseline. CIS-R=Clinical Interview Schedule—Revised. SF-12= Short-Form Health Survey.
The total CIS-R score assesses the severity of symptoms of common mental disorders. The total CIS-R score in three categories was a stratification variable at randomisation: 0–11 (minimal symptoms), 12–19 (moderate to severe symptoms), and ≥20 (severe symptoms).
A CIS-R diagnosis used the criteria and threshold required to meet an ICD-10 clinical diagnosis of depression or anxiety. CIS-R data were missing for one person.
The CIS-R depression severity score (possible range 0–21) assesses the severity of depressive symptoms.
How often during the past 2 weeks the patient had each symptom: 1 (not at all), 2 (several days), 3 (more than half the days), and 4 (nearly every day).