Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Timeline

Start

2008-06-27

Primary completion

2010-04-27

Completion

2010-04-27

Outcome

Missed primary endpoint

registry analysis (superiority test); SM-13496 (Lurasidone HCl) 40-mg Group vs Placebo Group; p = 0.149 NCT00711269 ↗

registry analysis (superiority test); SM-13496 (Lurasidone HCl) 80-mg Group vs Placebo Group; p = 0.462 NCT00711269 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	40 mg	Oral
Subject	Lurasidone	Small molecule	80 mg	Oral
Comparator	Risperidone	Other / unclassified	—	Oral

Indications