40 In a study evaluating the efficacy and safety of ARI plus lamotrigine (LTG) (n=178) compared with PLB plus LTG (n=173), the dual drug combination led to delay in the time to manic/mixed relapse which, however, did not reach statistical significance at week 52 (HR: 0.55; 95% CI: 0.30–1.03; P =0.058). 41 Maintenance study A 26-week, double-blind, PLB-controlled relapse prevention study of ARI 42 was followed by a prospective, 74-week, double-blind, PLB-controlled extension phase.
1
0.0580
0.0580