Conditions: Schizophrenia
Keywords: schizophrenia asenapine Once daily twice daily
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
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

Detailed description:
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

Arms:
arm 1: Patients will receive their entire daily dose of asenapine as a single dose in the evening arm 2: Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening

Interventions: intervention 1: Asenapine 10 mg daily in the evening intervention 2: Asenapine 5 mg twice daily
Intervention descriptions: intervention 1: The total daily dose of Asenapine will be given once daily in the evening intervention 2: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily

Protocol document: