At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 162 enrolled
Drug / intervention
Lurasidonedrug
Likely dose
Lurasidone 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
In Brief
A Phase 3 clinical trial evaluating Lurasidone for Schizophrenia and Bipolar Disorder. Completed, enrolled 162 participants across 46 sites in 12 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Bipolar Disorder
CountriesCanada, Colombia, Czechia, France, India, Lithuania, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedDec 2011
Primary CompletionFeb 2014
TodayJul 2026
First PostedDec 5, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.6 years ago
Interventions
Lurasidonedrug
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food