At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 488 enrolled
Drug / intervention
Lurasidone +3 moredrug
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 Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)
In Brief
A Phase 3 clinical trial evaluating Lurasidone, Quetiapine XR, and 1 other intervention for Schizophrenia. Completed, enrolled 488 participants across 65 sites in 5 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 effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedNov 2008
Primary CompletionJul 2010
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.6 years ago
Interventions
Lurasidonedrug
Lurasidone 80 mg tablets
Lurasidonedrug
Lurasidone 4 40 mg tablets
Quetiapine XRdrug
Quetiapine XR 600mg
Placebodrug
Matching Placebo to Lurasidone or Quetiapine