Once-Daily Asenapine for Schizophrenia

• Change in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: From baseline to day 14 ] [ Designated as safety issue: No ]
  The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7; thus the highest and lowest possible scores are 18 and 126
• Staff acceptance [ Time Frame: At day 14 ] [ Designated as safety issue: No ]
  A Staff Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable) will be administered to the ward Medication Nurse by the Research Nurse on day 14 of treatment

The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder.

The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

The investigators will randomly assign 30 patients newly admitted to Central Regional Hospital (CRH) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to 14 days of treatment with either asenapine 5 mg BID or asenapine 10 mg QHS.

The investigators will assess patient and staff acceptance on day 14. The investigators will assess staff acceptance on day 14. The investigators will assess changes in psychopathology (Brief Psychiatric Rating Scale) from baseline to day 14.

The investigators propose to achieve the following specific aims:

1. To compare the patient acceptance of once daily versus twice daily asenapine; The investigators hypothesize that patient acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
2. To compare the staff (medication nurses) acceptance of once daily versus twice daily asenapine; the investigators hypothesize that staff acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
3. To compare the changes in psychopathology with once daily versus twice daily asenapine; the investigators hypothesize that changes in psychopathology from baseline to day 14 will be similar for the two dosing strategies

• Drug: Asenapine 10 mg once daily in the evening
  The total daily dose of Asenapine will be given once daily in the evening
  Other Name: Saphris
• Drug: Asenapine 5 mg twice daily
  Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
  Other Name: Saphris

• Experimental: asenapine 10 mg daily in the evening
  Patients will receive their entire daily dose of asenapine as a single dose in the evening
  Intervention: Drug: Asenapine 10 mg once daily in the evening
• Active Comparator: asenapine 5 mg twice daily
  Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
  Intervention: Drug: Asenapine 5 mg twice daily

Inclusion Criteria:

• Male or female individuals,
• 18-65 years of age,
• who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder,
• who are newly admitted to Central Regional Hospital for treatment of an acute psychotic exacerbation,
• who provide signed informed consent to participate, will be included.

Exclusion Criteria:

• Females who are lactating or pregnant,
• individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded