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Keep this study
Lead
Duke University
With
Merck Sharp & Dohme LLC
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
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Females who are lactating or pregnant,
individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded
Clareo Health | Once-Daily Asenapine for Schizophrenia
