6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Phase 3 Completed 196 enrolled Organon and Co

Non-randomizedParallel-groupQuadruple-blindTreatment

Summary

This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

Timeline

Start: 2005-07
Primary completion: 2009-04
Completion: 2009-05

Outcome

Met primary endpoint

registry analysis (unspecified test); Asenapine vs Olanzapine; p = 0.0148; Mixed Model for Repeated Measurements NCT00174265 ↗

Publications

Results Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asenapine	Other / unclassified	5 mg	Subcutaneous
Subject	Asenapine	Other / unclassified	10 mg	Subcutaneous
Comparator	Olanzapine	Small molecule	5 mg	Oral
Comparator	Olanzapine	Small molecule	20 mg	Oral