Study | Study design | Diagnosis | Age, year (SD) | Cases number (male/female) | Treatment group, dose range (mean dose) | Treatment duration | Assessment tools | Region |
Loebel 2014a | Double-blind, parallel | BDI (DSM-IV-TR) | 41.2 (12.5) 41.3 (12.3) 42.0 (12.4) | 162 (75/87) 161 (70/91) 162 (64/98) | Placebo Lurasidone 20–60 (32) mg Lurasidone 80–120 (82) mg | 6 weeks | MADRS, HAM-A, CGI-BP, SDS, Q-LES-Q-SF | Africa, Asia, Europe, USA |
Loebel 2014b1 | Double-blind, parallel | BDI (DSM-IV-TR) | 42.6 (11.8) 41.0 (11.5) | 161 (85/76) 179 (93/86) | Placebo Lurasidone 20–120 (66) mg | 6 weeks | MADRS, HAM-A, CGI-BP, SDS, Q-LES-Q-SF | Africa, Asia, Europe, USA |
Suppes 2016a1 | Double-blind, parallel | BDI (DSM-IV-TR) | 44.1 (12.0) 43.1 (11.9) | 166 (73/93) 176 (85/91) | Placebo Lurasidone 20–120 (65) mg | 6 weeks | MADRS, HAM-A, CGI-BP, SDS, Q-LES-Q-SF | Asia, Europe, South America, USA |
DelBello 2017 | Double-blind, parallel | BDI (DSM-5) | 14.3 (2.0) 14.2 (2.2) | 170 (87/83) 173 (88/85) | Placebo Lurasidone 20–80 (33) mg | 6 weeks | CDCS-R, PARS, CGI-BP, Q-LES-Q | Asia, Europe, Mexico, USA |
Kato 2020 | Double-blind, parallel | BDI (DSM-5) | 41.3 (12.6) 42.6 (12.9) 43.2 (12.8) | 171 (77/94) 182 (87/95) 169 (81/88) | Placebo Lurasidone 20–60 (36) mg Lurasidone 80–120 (85) mg | 6 weeks | MADRS, HAM-A, CGI-BP, SDS | Asia, Europe |
Suppes 2016b | Double-blind, parallel | MDD-MF (DSM-IV-TR) | 46.4 (12.0) 43.6 (12.1) | 100 (28/72) 109 (36/73) | Placebo Lurasidone 20–60 (36) mg | 6 weeks | MADRS, HAM-A, CGI-S, SDS | Europe, USA |
BDI, bipolar I disorder; CDCS-R, Children’s Depression Rating Scale-revised; CGI-BP, clinical global impression - bipolar disorder severity; CGI-S, clinical global impression - severity; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, fifth edition; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revised; HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery-Asberg Depression Rating Scale; MDD-MF, major depressive disorder with mixed features; PARS, Paediatric Anxiety Rating Scale; Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire–short form; SDS, Sheehan Disability Scale.