Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)

This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.

Inclusion Criteria:

• Minimum age of 20 years

• Participants who meet at least one of the following:

  • current diagnosis of schizophrenia of residual subtype
  • received treatment with 3 or more antipsychotic drugs
  • treatment-refractory participants with schizophrenia
  • 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline

• Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

• Uncontrolled, unstable clinically significant medical condition
• Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
• Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
• Seizure disorder beyond childhood (12 years old or younger)
• History of neuroleptic malignant syndrome
• Allergy or sensitivity to drugs such as psychotropics and antipsychotics
• Known history of or currently treated for narrow angle glaucoma
• Parkinson's disease
• Diagnosis of schizoaffective disorder; schizophreniform disorder
• Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
• Diagnosis of borderline personality disorder
• Diagnosis of mental retardation or organic brain disorder
• Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
• Positive drug/alcohol tests at the Screening visit
• Imminent risk of self-harm or harm to others, in the Investigator's opinion
• Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
• Currently under involuntary inpatient confinement
• Use of a non-approved drug in Japan within 12 weeks prior to informed consent
• Previously treated in an asenapine study