Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Intervention: Asenapine
Intervention description: 5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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