Table 2.
Trial characteristics and baseline demographics
| Trial | Treatments | Dose (mg/d) | Proportion of maximum approved daily dose (%) | Number of patients randomised | Duration of active medication (weeks) | Number of centres (locations)* | Setting | Baseline demographics | Total discontinuation rate (%)† | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age (mean (SD)) | Proportion female (%) | Hamilton depression rating scale 21 (mean (SD)) | |||||||||
| 014 | Reboxetine | 8-10 | 67-83 | 126 | 8 | 33 (Europe, South America) | Inpatient and outpatient | 40 (12) | 67 | 26.8 (3.4) | 30 |
| Fluoxetine | 20-40 | 25-50 | 127 | 40 (12) | 65 | 26.9 (3.6) | 24 | ||||
| Placebo | — | — | 128 | 44 (12) | 54 | 27.4 (3.6) | 41 | ||||
| 015 | Reboxetine | 8-10 | 67-83 | 112 | 6 | 34 (North America, Europe, Australia) | Inpatient and outpatient | 46 (13) | 63 | 27.5 (5.1) | 21 |
| Imipramine | 150-200 | Inpatient: 50-67 Outpatient: 100-133 |
115 | 44 (11) | 67 | 26.9 (4.7) | 33 | ||||
| Placebo | — | — | 112 | 43 (12) | 48 | 27.1 (5.3) | 23 | ||||
| 016 | Reboxetine | 8-10 | 67-83 | 79 | 8 | 16 (Europe, South America, Australia) | Inpatient and outpatient | 44 (13) | 72 | 28.6 (5.3) | 25 |
| Fluoxetine | 20-40 | 25-50 | 89 | 44 (12) | 72 | 27.4 (4.1) | 23 | ||||
| 032 | Reboxetine | 8-10 | 67-83 | 43 | 8 | 5 (Asia) | Inpatient and outpatient | 41 (15) | 63 | 27.2 (5.4) | 35 |
| Fluoxetine | 20-40 | 25-50 | 42 | 36 (13) | 62 | 28.3 (5.3) | 31 | ||||
| 043 | Reboxetine | 8-10 | 67-83 | 183 | 24 | 23 (Europe) | Outpatient | 43 (13) | 69 | 27.4 (3.5) | 50 |
| Citalopram | 20-40 | 33-67 | 176 | 42 (12) | 60 | 27.4 (3.9) | 31 | ||||
| 045 | Reboxetine | 8 | 67 | 89 | 6 | 48 (Europe, Asia) | Inpatient and outpatient | 42 (11) | 63 | 26.4 (2.6) | 30 |
| Placebo | — | — | 87 | 41 (11) | 70 | 26.4 (2.6) | 23 | ||||
| 046 | Reboxetine | 8-10 | 67-83 | 265 | 8 | 94 (North America) | N/A | 40 (11) | 71 | 23.0 (5.5) | 25 |
| Paroxetine | 20-40 | 40-80 | 265 | 40 (12) | 69 | 22.8 (5.4) | 22 | ||||
| Placebo | — | — | 257 | 39 (12) | 70 | 23.0 (5.2) | 16 | ||||
| 047 | Reboxetine | 8-10 | 67-83 | 258 | 8 | 68 (North America) | N/A | 39 (12) | 74 | 24.2 (4.9) | 27 |
| Paroxetine | 20-40 | 40-80 | 262 | 40 (11) | 72 | 23.9 (5.4) | 28 | ||||
| Placebo | — | — | 254 | 37 (11) | 82 | 23.7 (4.8) | 23 | ||||
| 049 | Reboxetine | 8-10 | 67-83 | 107 | 6 | 9 (North America) | Outpatient | 40 (12) | 55 | 25.1 (2.6) | 35 |
| Placebo | — | — | 105 | 40 (11) | 58 | 25.3 (3.0) | 22 | ||||
| 050 | Reboxetine | 8-10 | 67-83 | 150 | 8 | 24 (North America) | Outpatient | 40 (11) | 63 | 25.6 (3.4) | 42 |
| Fluoxetine | 20-40 | 25-50 | 150 | 41 (11) | 66 | 26.0 (3.3) | 31 | ||||
| Placebo | 150 | 40 (11) | 60 | 25.5 (3.3) | 40 | ||||||
| 052 | Reboxetine | 8-10 | 67-83 | 159 | 8 | 41 (Europe) | N/A | 42 (12) | 63 | 24.2 (3.6) | 33 |
| Paroxetine | 20-40 | 40-80 | 166 | 45 (11) | 62 | 24.1 (3.4) | 20 | ||||
| 091 | Reboxetine | 10 | 83 | 28 | 6 | 3 (North America, South America) | Inpatient | 42 (N/A) | 46 | 35.7 (N/A) | 14 |
| Placebo | — | — | 28 | 40 (N/A) | 50 | 35.1 (N/A) | 57 | ||||
| Berlanga and Flores-Ramos 2006 | Reboxetine | 4-8 | 33-67 | 46 | 8 | 1 (Central America) | Outpatient | N/A | N/A | N/A | 10 |
| Citalopram | 20-40 | 33-67 | 55 | N/A | N/A | N/A | 25 | ||||
*Details on individual countries are provided in web table A.
†To comply with the intention to treat principle, missing data from discontinued patients were imputed by using the last observation carried forward method.
N/A, not available.