drugset / Trial / NCT01435928

PEARL Schizophrenia Maintenance

NCT01435928 ↗

Phase 3 Completed 676 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

Timeline

Start
2011-09
Primary completion
2013-08
Completion
2013-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Lurasidone vs Placebo; p = 0.039; Odds Ratio (OR) 0.66 (95% CI 0.45 to 0.98); Log Rank NCT01435928 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 40 mg —
Subject Lurasidone Small molecule 80 mg —

Indications