Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

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 long term among schizophrenic outpatients with chronic schizophrenia.

Timeline

Start

2008-12

Primary completion

2011-07

Completion

2011-07

Outcome

Met primary endpoint

paper the upper limit of the hazard ratio (1.295) was smaller than the prespecified noninferiority margin (1.93), noninferiority of lurasidone compared with QXR was demonstrated PMID 23583011 ↗

paper Twelve months of treatment with lurasidone met noninferiority criteria PMID 23583011 ↗

Publications

• Results Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
• Results Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
• Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	40 mg	—
Subject	Lurasidone	Small molecule	160 mg	—
Comparator	Quetiapine	Small molecule	200 mg	—
Comparator	Quetiapine	Small molecule	800 mg	—

Indications