Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Completed the short-term trial ( 041021 or 021022) Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial Sign a written informed consent for the 041512 trial. Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator Exclusion Criteria: CGI-S score of greater or equal to 6 ( severely psychotic) Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation Met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022) Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Other
1
2
3
Olanzapine 20 mg QD
Asenapine 5 or 10 mg BID
Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52 week trial.