A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
Status:
Completed
Trial end date:
2014-09-09
Target enrollment:
Participant gender:
Summary
The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually
twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms)
as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15
mg orally once daily (QD) was used as an active control. The primary hypothesis is that at
least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms
as measured by the change from Baseline in the PANSS total score at Day 42. The first key
secondary hypothesis is that at least one of the asenapine doses is superior to placebo in
improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global
Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is
that at least one of the asenapine doses is superior to placebo in improving schizophrenia
symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS
Total Score) at Day 42.