A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688 AM2)

The trial consists of a screening/tapering period, treatment period, and follow-up period.
The 6-week active treatment period includes an inpatient phase and outpatient phase.
Participants who complete the trial may continue treatment under a long-term extension
protocol (P05689). Participants who do not continue in the treatment continuation trial
(whether they complete the 6-week trial or discontinue prematurely) will have a follow-up
visit 7 days after their last dose of trial medication.

Inclusion Criteria:

- Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated
subtype

- Minimum PANSS total score of 70 at Screening and Baseline

- Score of at least 4 (moderate) in two or more of the five items in the positive
subscale of the PANSS

- Confirmed to be experiencing an acute exacerbation of schizophrenia

- CGI-S scale score of at least 4 (moderately ill) at Baseline

- Has responded positively to an antipsychotic medication other than clozapine
(Clozaril®) in a prior episode

Exclusion Criteria:

- Body mass index (BMI) <18.5 or >40.0 kg/m^2

- Laboratory and/or clinical evidence of clinically significant hepatic conditions

- Known history of, or undergoing treatment for, narrow angle glaucoma

- Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile
seizures

- Known serological evidence of human immunodeficiency virus (HIV) antibody

- History of neuroleptic malignant syndrome or tardive dyskinesias

- Past or current diagnosis of schizoaffective disorder, schizophrenia of residual
subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with
course specifiers continuous, single episode in partial remission, or single episode
in full remission, or borderline personality disorder