TABLE 1.
Study characteristics.
| Study name | Key inclusion criteria | AD trial prior to randomization | Treatment arm | N | AD | Mean age (mean ± SD) | Male | MADRS at baseline (mean ± SD) | Patients with recurrent episode |
|---|---|---|---|---|---|---|---|---|---|
| Kamijima 2013 (Japan) | MDD (DSM‐IV‐TR), HAMD17 ≥ 18, and inadequate response to 1–3 AD trials | Inadequate response (<50% reduction in the HAMD17), HAM‐D17 ≥ 14, or CGI‐I ≥ 3 | ARI 3 mg/day | 197 | DUL (9.6%), FLU (20.0%), MIL (12.8%), PAR (19.3%), SER (38.4%) | 38.7 ± 9.3 | 58.0% | 25.3 ± 7.3 | 42.5% |
| ARI 3–15 mg/day (final mean dose: 9.8 mg/day) | 194 | ||||||||
| PLA | 195 | ||||||||
| Kamijima 2018 a (Japan and other countries) | MDD (DSM‐5), HAMD17 ≥ 18, and inadequate response to 1–3 AD trials | Inadequate response (<50% reduction in the HAMD17), HAM‐D17 ≥ 14, or CGI‐I ≥ 3 | ARI 3–12 mg/day (final mean dose: 6.3 mg/d) | 209 | SER (100.0%) | 38.9 ± 11.8 | 63.3% | 25.0 ± 6.5 | 52.8% |
| PLA | 203 | ||||||||
| Kato 2023 (Japan) | MDD (DSM‐5), HAMD17 ≥ 18, and inadequate response to 1–3 AD trials | Inadequate response (<50% reduction in the HAMD17), HAM‐D17 ≥ 14, or CGI‐I ≥ 3 | BRE 1 mg/day | 250 | DUL (17.6%), ESC (30.7%), FLU (3.8%), MIL (2.4%), PAR (5.1%), SER (30.5%), VEN (9.3%) | 40.2 ± 10.7 | 56.1% | 27.0 ± 6.5 | 61.4% |
| BRE 2 mg/day | 245 | ||||||||
| PLA | 243 |
Abbreviations: AD, antidepressant; BRE, brexpiprazole; d, day; DSM, Diagnostic and Statistical Manual of Mental Disorders; DUL, duloxetine; ESC, escitalopram; FLUV, fluvoxamine; HAMD17, 17‐item Hamilton Depression Rating Scale of depression; MADRS, Montgomery Åsberg Depression Rating Scale; MDD, major depressive disorder; MIL, milnacipran; N, number of patients; PAR, paroxetine‐immediate release; PLA, placebo; SD, standard deviation; SER, sertraline; VEN‐XR, venlafaxine‐extended release.
a
Most participants were enrolled in Japan (72.7%).