Introduction: Asenapine is FDA-approved in adults for acute treatment of schizophrenia or of manic or mixed episodes associated with bipolar I disorder with or without psychotic features. We report post hoc analyses of asenapine effects on depressive symptoms in 2 randomized placebo-controlled 3-week trials in bipolar I disorder patients experiencing acute manic or mixed episodes.
Methods: LS mean changes from baseline were assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression for Bipolar Disorder–Depression scale (CGI-BP-D) in 3 subgroups: Group 1, baseline MADRS score >=20 (45 and 33 patients taking asenapine and placebo, respectively); Group 2, baseline CGI-BP-D score >=4 (59 and 37); Group 3, patients with mixed episodes (111 and 68).
Results: Results are shown for asenapine vs placebo. Group 1: changes on MADRS were –11.26 vs –4.48 (P=0.002) on day 7 and –13.58 vs –6.99 (P=0.009) on day 21; changes on CGI-BP-D were –1.00 vs –0.36 (P=0.011) and –1.43 vs –0.65 (P=0.02). Group 2: changes on MADRS were –7.70 vs –3.61 (P=0.023) on day 7 and –9.90 vs –5.41 (P=0.030) on day 21; changes on CGI-BP-D were –1.17 vs –0.58 (P=0.015) and –1.56 vs –1.18 (P=NS). Group 3: changes on MADRS were –6.69 vs –3.63 (P=0.011) on day 7 and –8.29 vs –5.73 (P=NS) on day 21; changes on CGI-BP-D were –0.71 vs –0.29 (P=0.007) and –1.02 vs –0.68 (P=NS).
Conclusion: This post hoc analysis suggests asenapine may effectively reduce depressive symptoms in bipolar I disorder patients exhibiting these symptoms at baseline.