This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
Time frame: 18 months
Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Time frame: 18 months
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