Abstract
BackgroundThe current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients.MethodsBipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS).ResultsThe most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time.LimitationsNo control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study.ConclusionsLong-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident.Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114.
Highlights
Bipolar disorder is a chronic and disabling disorder that affects both social and occupational functioning to an extensive degree (Dean et al 2004; Fajutrao et al 2009; Gardner et al 2006; Vos et al 2012)
In Japan, clinical guidelines have recommended the use of lithium, sodium valproate (VPA), and several atypical antipsychotic agents in the treatment of mania episodes associated with bipolar disorder (Kanba et al 2013)
The demographic and clinical characteristics of these 7 patients were comparable to the characteristics of the patients who did enroll in the 52 week trial
Summary
Bipolar disorder is a chronic and disabling disorder that affects both social and occupational functioning to an extensive degree (Dean et al 2004; Fajutrao et al 2009; Gardner et al 2006; Vos et al 2012). Though the majority of patients with bipolar disorder experience recurrent depressed episodes more commonly than manic or hypomanic episodes (Calabrese et al 2004; Judd et al 2002), about half of those with mania experience severe role impairment (Merkiangas et al 2011). Those individuals with bipolar I disorder have been found to be symptomatic on average approximately 70% of the time (Forte et al 2015). The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
