Once-Daily Asenapine for Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | March 2012 |
| End Date: | July 2013 |
| Contact: | Joseph P McEvoy, MD |
| Email: | jpmcevoy@duke.edu |
| Phone: | 919-819-9295 |
A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia
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
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
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
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
We found this trial at
1
site
Click here to add this to my saved trials
