Study; drug, mg/d | Jadad score | Mean age, yr | Sex, % female | Duration, wk | No. treated | Baseline HAM-D/MADRS score | Baseline CGI-S score | Study location | Primary end point | Entry Score† |
---|---|---|---|---|---|---|---|---|---|---|
Alvarez et al.24 | 4 | 6 | Europe/Asia | MADRS | ≥30 | |||||
PBO | 42.0 | 65.7 | 105 | 33.9 ± 2.7 | 5.1 ± 0.7 | |||||
VTX, 5 | 43.8 | 64.8 | 108 | 34.1 ± 2.6 | 5.2 ± 0.7 | |||||
VTX, 10 | 42.3 | 66.0 | 100 | 34.0 ± 2.8 | 5.1 ± 0.7 | |||||
VFX, 225 | 45.0 | 54.9 | 113 | 34.2 ± 3.1 | 5.2 ± 0.7 | |||||
Henigsberg et al.27 | 4 | 8 | Europe/Asia/Africa | HAM-D | ≥ 26 | |||||
PBO | 46.4 | 61.4 | 140 | 32.7 ± 4.4 | 4.8 ± 0.8 | |||||
VTX, 1 | 45.4 | 66.4 | 140 | 32.5 ± 5.1 | 4.8 ± 0.7 | |||||
VTX, 5 | 47.3 | 62.1 | 140 | 32.1 ± 5.0 | 4.7 ± 0.7 | |||||
VTX, 10 | 46.4 | 60.7 | 139 | 33.1 ± 4.8 | 4.9 ± 0.8 | |||||
Baldwin et al.25 | 5 | 8 | Europe/Asia | MADRS | ≥ 26 | |||||
PBO | 43.4 | 69.6 | 148 | 29.8 ± 5.1 | 4.8 ± 0.7 | |||||
VTX, 2.5 | 46.0 | 71.0 | 155 | 29.6 ± 5.8 | 4.8 ± 0.7 | |||||
VTX, 5 | 44.7 | 66.2 | 157 | 31.3 ± 5.8 | 4.8 ± 0.7 | |||||
VTX, 10 | 45.2 | 68.1 | 151 | 30.4 ± 5.4 | 4.8 ± 0.7 | |||||
DLX, 60 | 45.3 | 67.7 | 155 | 29.9 ± 5.8 | 4.7 ± 0.7 | |||||
Katona et al.30‡ | 4 | 8 | USA/Europe/Asia | HAM-D | ≥ 26 | |||||
PBO | 70.3 | 62.1 | 145 | 29.4 ± 5.1 | 4.7 ± 0.7 | |||||
VTX, 5 | 70.5 | 68.6 | 156 | 29.2 ± 5.0 | 4.8 ± 0.7 | |||||
DLX, 60 | 70.9 | 66.2 | 151 | 28.5 ± 4.9 | 4.7 ± 0.8 | |||||
Mahableshwarkar et al.29 | 5 | 8 | USA | HAM-D§ | ≥ 22 | |||||
PBO | 42.6 | 60.8 | 153 | 29.5 ± 6.1 | 4.5 ± 0.6 | |||||
VTX, 2.5 | 42.6 | 64.1 | 153 | 29.8 ± 5.4 | 4.6 ± 0.6 | |||||
VTX, 5 | 43.1 | 69.3 | 153 | 29.8 ± 4.5 | 4.6 ± 0.7 | |||||
DLX, 60 | 42.7 | 59.9 | 152 | 29.4 ± 4.4 | 4.5 ± 0.7 | |||||
Jain et al.28 | 5 | 6 | USA | HAM-D§ | ≥ 30 | |||||
PBO | 42.4 | 54.7 | 298 | 32.2 ± 5.5 | 4.8 ± 0.7 | |||||
VTX, 5 | 42.5 | 62.0 | 299 | 32.7 ± 5.4 | 4.8 ± 0.7 | |||||
Boulenger et al.26 | 4 | 8 | Europe | MADRS | ≥ 26 | |||||
PBO | 48.1 | 69.6 | 158 | 31.5 ± 3.6 | 4.9 ± 0.7 | |||||
VTX, 15 | 47.0 | 64.2 | 151 | 31.8 ± 3.4 | 4.9 ± 0.6 | |||||
VTX, 20 | 46.2 | 60.3 | 151 | 31.2 ± 3.4 | 4.8 ± 0.7 | |||||
DLX, 60 | 45.6 | 69.4 | 147 | 31.2 ± 3.5 | 4.8 ± 0.7 | |||||
Mahableshwarkar et al.32 | 4 | 8 | USA | MADRS | ≥ 26 | |||||
PBO | 42.4 | 72.0 | 161 | 31.6 ± 4.18 | 4.6 ± 0.6 | |||||
VTX, 15 | 43.1 | 70.7 | 147 | 31.9 ± 4.08 | 4.5 ± 0.6 | |||||
VTX, 20 | 42.8 | 74.0 | 154 | 32.0 ± 4.36 | 4.5 ± 0.6 | |||||
DLX, 60 | 43.4 | 78.3 | 152 | 32.9 ± 4.39 | 4.5 ± 0.6 | |||||
Jacobsen et al.31 | 4 | 8 | USA | MADRS | ≥ 26 | |||||
PBO | 42.3 | 70.1 | 157 | 32.0 ± 4.0 | 4.5 ± 0.6 | |||||
VTX10 | 43.1 | 76.1 | 155 | 32.3 ± 4.5 | 4.5 ± 0.6 | |||||
VTX20 | 43.1 | 71.3 | 150 | 32.4 ± 4.3 | 4.5 ± 0.5 | |||||
Mahableshwarkar et al.33 | 4 | 8 | USA | MADRS | ≥ 26 | |||||
PBO | 46.2 | 67.5 | 160 | 33.4 ± 4.5 | 4.7 ± 0.6 | |||||
VTX10 | 45.2 | 72.0 | 154 | 34.1 ± 4.1 | 4.7 ± 0.6 | |||||
VTX15 | 43.8 | 71.1 | 151 | 33.7 ± 4.5 | 4.6 ± 0.6 | |||||
NCT0125578734 | 4 | 8 | Europe/Asia | MADRS | ≥ 26 | |||||
PBO | 43.6 | 59.9 | 152 | 31.6 ± 3.6 | 4.7 ± 0.7 | |||||
VTX, 5 | 44.2 | 68.1 | 144 | 31.6 ± 3.7 | 4.7 ± 0.7 | |||||
VTX, 10 | 45.7 | 62.0 | 148 | 31.8 ± 4.0 | 4.7 ± 0.7 | |||||
VTX, 20 | 44.0 | 62.0 | 150 | 31.7 ± 3.7 | 4.7 ± 0.7 | |||||
Dragheim et al.35 | 4 | 12 | Europe | MADRS | ≥ 22 | |||||
VTX, 10–20 | 47.0 | 77.1 | 253 | 29.1 ± 4.4 | 4.4 ± 0.6 | |||||
AGO, 25–50 | 45.6 | 72.3 | 242 | 28.7 ± 4.0 | 4.4 ± 0.6 |
AGO = agomelatine; CGI-S = Clinical Global Impression — Severity scale; DLX = duloxetine; HAM-D = Hamilton Rating Scale for Depression; MADRS = Montgomery–Åsberg Depression Rating Scale; PBO = placebo; VTX =vortioxetine.
↵* Based on randomized set or all-patients-treated set.
↵† By MADRS total score.
↵‡ Elderly population.
↵§ Remission criteria by 50% reduction in MADRS total score at the end point.