Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Completed the short-term 041023 trial (NCT00156104) 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 041513 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 (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic) Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial 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
Experimental
Haloperidol/Haloperidol
Asenapine/Asenapine
Placebo/Asenapine
Haloperidol in original study (NCT00156104) and in current long-term extension.
Asenapine in original study and asenapine in current long-term extension.
Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 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.