Real-world Effectiveness and Tolerability of Lurasidone in Outpatients with Bipolar DisorderII- A 24 week retrospective study (RETLO-BDIIstudy).

Objective: We conducted a retrospective study to investigate the efficacy and safety of lurasidone (LUR) in outpatients with depressive episodes of bipolar disorder II (BD2) in real world setting.

Methods: We retrospectively analyzed the clinical data obtained from the medical records of the Horikoshi Psychosomatic Clinic between February 2020 and April 2022. A total of 78 patients with BD2 who experienced a depressive episode were included in this study. The primary outcome was the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to 8 weeks (W). The secondary outcome was the mean change in the MADRS score from baseline to 2, 4, and 12 W. Discontinuation and adverse event rates were measured after 24 W.

Results: After starting LUR, the mean total score of the MADRS significantly decreased at 8 W (-11.8 ± 8.26, P < 0.0001). Patients with BD2 who underwent the treatment with LUR showed significantly great improvement at 2 W (-8.38 ± 8.75, P< 0.0001), 4 W (-11.2 ± 8.36 P < 0.0001), and 24 W (-11.6 ± 7.29, P < 0.0001). The discontinuation and adverse event rates in patients who underwent LUR were 23.1 % and 37.2 %, respectively.

Conclusions: LUR significantly improved depressive symptoms in patients with BD2 at 8 W. Moreover, treatment with LUR resulted in early improvement at 2 W and efficacy for 24 weeks. In summary, LUR demonstrated effectiveness and safety in acute depressive episodes of BD2, including mid-term efficacy in real-world clinical settings.