Table 1

Summary of currently available short-term randomized, double-blind, placebo-controlled clinical trials of vortioxetine for the treatment of patients with major depressive disorder*

Study; drug, mg/dJadad scoreMean age, yrSex, % femaleDuration, wkNo. treatedBaseline HAM-D/MADRS scoreBaseline CGI-S scoreStudy locationPrimary end pointEntry Score
Alvarez et al.2446Europe/AsiaMADRS≥30
 PBO42.065.710533.9 ± 2.75.1 ± 0.7
 VTX, 543.864.810834.1 ± 2.65.2 ± 0.7
 VTX, 1042.366.010034.0 ± 2.85.1 ± 0.7
 VFX, 22545.054.911334.2 ± 3.15.2 ± 0.7
Henigsberg et al.2748Europe/Asia/AfricaHAM-D≥ 26
 PBO46.461.414032.7 ± 4.44.8 ± 0.8
 VTX, 145.466.414032.5 ± 5.14.8 ± 0.7
 VTX, 547.362.114032.1 ± 5.04.7 ± 0.7
 VTX, 1046.460.713933.1 ± 4.84.9 ± 0.8
Baldwin et al.2558Europe/AsiaMADRS≥ 26
 PBO43.469.614829.8 ± 5.14.8 ± 0.7
 VTX, 2.546.071.015529.6 ± 5.84.8 ± 0.7
 VTX, 544.766.215731.3 ± 5.84.8 ± 0.7
 VTX, 1045.268.115130.4 ± 5.44.8 ± 0.7
 DLX, 6045.367.715529.9 ± 5.84.7 ± 0.7
Katona et al.3048USA/Europe/AsiaHAM-D≥ 26
 PBO70.362.114529.4 ± 5.14.7 ± 0.7
 VTX, 570.568.615629.2 ± 5.04.8 ± 0.7
 DLX, 6070.966.215128.5 ± 4.94.7 ± 0.8
Mahableshwarkar et al.2958USAHAM-D§≥ 22
 PBO42.660.815329.5 ± 6.14.5 ± 0.6
 VTX, 2.542.664.115329.8 ± 5.44.6 ± 0.6
 VTX, 543.169.315329.8 ± 4.54.6 ± 0.7
 DLX, 6042.759.915229.4 ± 4.44.5 ± 0.7
Jain et al.2856USAHAM-D§≥ 30
 PBO42.454.729832.2 ± 5.54.8 ± 0.7
 VTX, 542.562.029932.7 ± 5.44.8 ± 0.7
Boulenger et al.2648EuropeMADRS≥ 26
 PBO48.169.615831.5 ± 3.64.9 ± 0.7
 VTX, 1547.064.215131.8 ± 3.44.9 ± 0.6
 VTX, 2046.260.315131.2 ± 3.44.8 ± 0.7
 DLX, 6045.669.414731.2 ± 3.54.8 ± 0.7
Mahableshwarkar et al.3248USAMADRS≥ 26
 PBO42.472.016131.6 ± 4.184.6 ± 0.6
 VTX, 1543.170.714731.9 ± 4.084.5 ± 0.6
 VTX, 2042.874.015432.0 ± 4.364.5 ± 0.6
 DLX, 6043.478.315232.9 ± 4.394.5 ± 0.6
Jacobsen et al.3148USAMADRS≥ 26
 PBO42.370.115732.0 ± 4.04.5 ± 0.6
 VTX1043.176.115532.3 ± 4.54.5 ± 0.6
 VTX2043.171.315032.4 ± 4.34.5 ± 0.5
Mahableshwarkar et al.3348USAMADRS≥ 26
 PBO46.267.516033.4 ± 4.54.7 ± 0.6
 VTX1045.272.015434.1 ± 4.14.7 ± 0.6
 VTX1543.871.115133.7 ± 4.54.6 ± 0.6
NCT012557873448Europe/AsiaMADRS≥ 26
 PBO43.659.915231.6 ± 3.64.7 ± 0.7
 VTX, 544.268.114431.6 ± 3.74.7 ± 0.7
 VTX, 1045.762.014831.8 ± 4.04.7 ± 0.7
 VTX, 2044.062.015031.7 ± 3.74.7 ± 0.7
Dragheim et al.35412EuropeMADRS≥ 22
 VTX, 10–2047.077.125329.1 ± 4.44.4 ± 0.6
 AGO, 25–5045.672.324228.7 ± 4.04.4 ± 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.