At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 412 enrolled
Drug / intervention
Lurasidone +2 moredrug
Likely dose
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2from 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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose Lurasidone in Acutely Psychotic Subjects With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Lurasidone, Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2, and 1 other intervention for Schizophrenia. Completed, enrolled 412 participants across 66 sites in 6 countries.
Detailed Summary
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesColombia, Romania, Russia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedApr 1, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.3 years ago
Interventions
Lurasidonedrug
Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2drug
Lurasidone 80 mg once daily
Placebodrug
Once Daily