Once-Daily Asenapine for Schizophrenia

Study Overview
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Brief Summary
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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
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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: 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 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 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

Official Title
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A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Asenapine 10 mg daily in the evening
* Drug: Asenapine 5 mg twice daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asenapine 10 mg daily in the evening<br>Patients will receive their entire daily dose of asenapine as a single dose in the evening | Drug: Asenapine 10 mg daily in the evening<br>* The total daily dose of Asenapine will be given once daily in the evening<br>* Other names: Saphris;|
| Active Comparator: asenapine 5 mg twice daily<br>Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening | Drug: Asenapine 5 mg twice daily<br>* Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily<br>* Other names: Saphris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptance | A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment. | At day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Psychiatric Rating Scale (BPRS) Total Score | The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126 | From baseline to day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, asenapine, Once daily, twice daily