Table 2.

Asenapine in the treatment of depressive symptoms of bipolar disorder

Study	Patient population	Relevant primary outcome measure(s)	Outcomes summary
Azorin et al26	Patients meeting DSM-IV-TR criteria for mixed episode	Change in MADRS score from baseline at treatment days 21 and 84	At day 21, asenapine was superior to placebo, while olanzapine was not superior to placebo; at day 84 asenapine was not statistically significantly superior to olanzapine
Berk et al27	Patients meeting DSM-IV-TR criteria for moderate-to-severe depression in mixed episode (baseline MADRS ≥20)	Change in MADRS score from baseline at treatment days 7 and 21	At day 7, decreases in MADRS were greater for asenapine than for placebo and olanzapine. At day 21, asenapine was superior to placebo, but not olanzapine
McIntyre et al28	Patients with positive subscale responses on MADRS or PANSS	Remission of depressive symptoms (MADRS ≤12) at study endpoint	MADRS remission was superior with asenapine compared to placebo
Szegedi et al29	Mixed episode or MADRS ≥20 or CGI-BP ≥4	Change in MADRS and CGI-BP from baseline at treatment days 7 and 21	Decrease in MADRS was greater for asenapine than placebo, but not olanzapine, at day 7 and day 21. CGI-BP improved more for asenapine than placebo at day 7, but not day 21

Abbreviations: MADRS, Montgomery–Åsberg Depression Rating Scale; PANSS, Positive and Negative Syndrome Scale; CGI-BP, Clinical Global Impression-Bipolar; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders IV Text Revision.