Table 7.
Group | Suicidality TEAE | Suicidal Ideation (C-SSRS) | Suicidal Behavior (C-SSRS) | Any Suicidality |
---|---|---|---|---|
Placebo | 0/56a (0.0) | 2/56 (3.6) | 0/56 (0.0) | 2/56 (3.6) |
Cariprazine 1.5–6 mg | 7/503a (1.4) | 19/503 (3.8) | 4/503 (0.8) | 26/503 (5.2) |
Note: aSuicidality in patients with reports of akathisia or restlessness TEAEs, or akathisia according to the Barnes Akathisia Rating Scale.
Abbreviations: C-SSRS, Columbia–Suicide Severity Rating Scale; TEAE, treatment-emergent adverse event.