Pediatric Schizophrenia Efficacy and Safety Study

Summary

Efficacy and Safety study of Lurasidone in pediatric patients.

Timeline

Start

2013-08

Primary completion

2015-12

Completion

2015-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Lurasidone 40 mg vs Placebo; p = 0.0003; LS mean difference (SE) -8.0 (95% CI -12.4 to -3.7); NCT01911429 ↗

registry analysis (superiority or other test); Lurasidone 80 mg vs Placebo; p = 0.0006; LS mean difference (SE) -7.7 (95% CI -12.1 to -3.4); NCT01911429 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	40 mg	—
Subject	Lurasidone	Small molecule	80 mg	—

Indications