TABLE 5.
Study | Patient Population | Treatment Groups | Difference in Suicidality (CGI‐SS‐r) @ 24 h a | Baseline MADRS score (0–60) | Change from baseline @ 24 h | LS Mean fr placebo (SE) | p Value v Placebo |
---|---|---|---|---|---|---|---|
Canuso et al. Am J Psychiatry 2018 (PERSEVERE) 31 | N = 68, age 18–64 Acutely suicidal b | Esk 84 mg twice weekly + AD | NS | 38.5 | −19.2 | ‐7.2 (2.85) | p = < 0.05 |
Placebo twice weekly + Ad c | — | 38.8 | −12.0 | — | — | ||
Fu et al. J Clin Psychiatry 2020 (ASPIRE‐1) 33 | N = 226, age 18–64 Acutely suicidal | Esk 84 mg twice weekly + AD | NS | 41.3 | −16.4 | −3.8 (1.39) | p < 0.05 |
Placebo twice weekly + AD | — | 41.0 | −12.8 | — | — | ||
Ionescu et al. Neuropsychopharmacol 2021 (ASPIRE‐2) 32 | N = 230, age 18–64 Acutely suicidal | Esk 84 mg twice weekly + AD | NS | 39.5 | −15.7 | −3.9 (1.39) | p < 0.05 |
Placebo twice weekly + AD | — | 39.9 | −12.4 | — | — |
Abbreviations: AD, anti‐depressant; CGI‐SS‐r, Clinical Global Impression‐Severity of Suicidalty‐revised; LS Mean, least squares mean; MADRS, Montgomery Asberg Depression Rating Scale; NS, Not statistically significant; SE, standard error.
Difference from placebo by Analysis of Covariance.
Acutely suicidal is suicidal ideation with intent assessed in emergency department or hospital inpatient unit.
Standard‐of‐care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant therapy).