A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

NCT01617187 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Organon and Co
Phase	PHASE3
Status	COMPLETED
Enrolment	360
Start date	Tue Dec 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Sep 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Schizophrenia

Interventions

• Asenapine
• Placebo Asenapine
• Olanzapine
• Placebo Olanzapine