Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

Inclusion Criteria:

• Each participant must have schizophrenia, diagnosed and confirmed by board-eligibleor board certified psychiatrists with at least two years of specialization inpediatric/adolescent psychiatric medicine.

• Each participant must be ≥12 years of age and <18 years of age.

• Each participant must have a minimum PANSS total score of 80 at Screening andBaseline.

• Each participant must have a score of at least 4 (moderate) on two or more of thefive items in the positive subscale of the PANSS (delusions, conceptualdisorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution)at Screening and Baseline.

• Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.

• Each participant must taper off all prohibited psychotropic medications (includingantipsychotics, antidepressants, and mood stabilizers) prior to Baseline.

• Each participant must agree not to begin formal, structured psychotherapy during thetrial.

Exclusion Criteria:

• A participant must not have a diagnosis of schizoaffective disorder; schizophreniaof residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in fullremission" course specifiers.

• A participant must not have a primary Axis I diagnosis other than schizophrenia andmust not have a comorbid Axis I diagnosis that is primarily responsible for currentsymptoms and functional impairment.

• A participant must not have a known or suspected diagnosis of mental retardation ororganic brain disorder.

• A participant must not currently (within the past 6 months) meet the Diagnostic andStatistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria forsubstance abuse or dependence (excluding nicotine).

• A participant must not have a diagnosis of psychotic disorder or a behavioraldisturbance thought to be substance induced or due to substance abuse.

• A participant must not be at imminent risk of self-harm or harm to others, in theinvestigator's opinion based on clinical interview and responses provided on theColumbia Suicide Severity Rating Scale (C-SSRS).