At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 629 enrolled
Drug / intervention
Lurasidone HCl +1 moredrug
Likely dose
Lurasidone HCl 120mgfrom 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.
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Lurasidone HCl and Risperidone for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 629 participants across 73 sites in 8 countries.
Detailed Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesArgentina, Brazil, Chile, Croatia, Israel, South Africa, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionJul 2010
TodayJul 2026
First PostedMar 24, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.3 years ago
Interventions
Lurasidone HCldrug
40 - 120mg per day
Risperidonedrug
Risperidone