Evaluating Moderating Effects of Sleep Disturbance and Irritability in the Two-Year Open-Label Extension Study
irritability, YMRS
Lurasidone showed continued improvement in decreased need for sleep and irritability, as well as the overall CDRS-R and CGAS scores in the open-label extension study (Figs. The presence of symptoms involving “decreased need for sleep” (YMRS item 4) and “irritability” (YMRS item 5) at extension baseline predicted trajectories of antidepressant (as assessed by CDRS-R score) and functioning (as assessed by CGAS score) responses to lurasidone treatment during the two-year, open-label extension study (Figs. For the participants who had no symptoms of sleep and irritability (YMRS item 4 =0 and YMRS item 5 =0) at extension study baseline, lurasidone was associated with a long-term maintenance effect on the CDRS-R and CGAS scores observed at baseline of the open-label extension study (Figs. The absence of both “decreased need for sleep” (YMRS item 4) and “irritability” (YMRS item 5) (