6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

Inclusion Criteria

• •current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
• •minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.
• •participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.
• •participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:
• •* at the screening test, the duration of the current episode was no more than 2 months;
• •* current symptoms represented a dramatic and substantial change compared to the participant's symptomatic state prior to the emergence of the current episode;
• •* participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.
• •participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
• •responded positively to an antipsychotic medication in a prior episode.
• •discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
• •participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.